PK/PD and Other Jobs

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Contact email address: telder@greylock-recruiting.com - 8th Feb 2008 [1381]

Principal Scientist In Vivo

Big Pharma Company Seeks:

The individual will be active in practical laboratory work related to in vivo studies and pharmacokinetic data analysis for timely ADME_PK support of drug discovery. The individual will provide leadership in designing and carrying out in vivo experiments related to the investigation of the pharmaceutical properties of drug candidates including absorption, distribution and clearance processes. In this capacity, this position will require interaction with biologists and chemists in therapeutic project teams to aid in data interpretation and study design in animal studies. The individual will develop and employ experimental techniques aimed at elucidating mechanisms controlling pharmacokinetic behavior including such techniques as catheterization, sampling of tissues and fluids including blood, plasma, urine and CSF. The individual will introduce new and established experimental techniques such as microdialysis to the elucidation of pharmacokinetic questions. This individual will be capable of calculating and interpreting key pharmacokinetic parameters. The individual will ensure proper recording of information to ensure the generation of final study reports.

A PhD with 7-12 years business experience is required. A degree in pharmacology, toxicology or a related field is required. The following work-related qualifications are required to carry out the job functions: extensive experience of in vivo models for the evaluation of pharmacokinetic properties; development of new pharmacological models; skills in organizing, planning and problem solving; leadership, communication and interpersonal skills. A practical knowledge of pharmacokinetic data analysis and interpretation of physicochemical properties, permeability, metabolism, and drug-drug interaction data is required. Some understanding of surgical techniques is desirable. Other requirements include a demonstrated ability to collaborate effectively with other scientists in various R&D organizations; a track record of managing multiple priorities and tasks simultaneously; a proven capability to deliver, communicate, and present analytical results in a timely manner; supervisory potential and a displayed ability to work in a multidisciplinary team environment. Experience of Physiological Pharmacokinetic modeling is highly preferred.

External website http://www.pkrecruiting.com

Contact email address: stephane.dezerable@kornferry.com - 7th Feb 2008 [1380]

CYTOMICS PHARMACEUTICALS is a biopharmaceutical company dedicated to the discovery and development of small molecules controlling protein turnover, to treat serious human diseases. The company was founded in April 2000 and started to operate in 2003.

The protein turnover regulation approach of CYTOMICS PHARMACEUTICALS focused on the Ubiquitin-Proteasome pathway is enabled by a solid foundation of biochemistry and molecular biology. As a result, CYTOMICS PHARMACEUTICALS has developed UbiScreen™, an innovative high-throughput screening technology that is amenable to a large spectrum of novel or existing targets in various therapeutic areas. Strategically, CYTOMICS PHARMACEUTICALS has elected to exploit UbiScreen™ in both cancer and nosocomial fungal infections.

As the Company is advancing toward the pre-clinical development of NCEs generated from its discovery programs and hit-to-lead activities, it is looking for an experienced in-vivo pharmacologist with a proven ability to exploit the full biological potential of NCEs associated with novel targets and ultimately move them into the clinic.

To date, CYTOMICS PHARMACEUTICALS has raised a total of about 20 million € in equity and grants. The company has 24 employees, including 10 PhDs and operates in a newly completed state-of-the-art facility.

Duties and Responsibilities Seeking highly motivated individual primarily responsible for the conduct and reporting of all non-GLP and GLP studies in small animal species. This includes protocol design, study monitoring, interpretation of study findings, and report writing, as well as a leading role in all pre-clinical regulatory activities. Specific duties include: * Primary responsibility of all in-vivo studies including proof-of-concept data, toxicity, and ADME parameters. * Identification, evaluation and management of all in-vivo related CROs * Integrating pre-clinical work with future CMC and clinical functions of CYTOMICS PHARMACEUTICALS. Person Specification

Education: Ph.D in a biological science field. Professional experience: 5 years of research experience at CRO, biotechnology or pharmaceutical company in performing in-vivo studies. Comprehensive and demonstrated knowledge of management of all pre-clinical activities that relate to in-vivo experiments and integrated in the context of drug discovery and pre-clinical development Excellent written and verbal communications skills. Fluent English is a pre-requisite. To apply, please send an email to clara.sini@futurestep.com mentionning reference FMSD60657

External website http://www.futurestep.com/

Contact email address: telder@greylock-recruiting.com - 6th Feb 2008 [1379]

Manager/Sr. Manager, Phase 1 Biostatistics

M.S or PhD. in Statistics or Biostatistics with a minimum of 3 years experience in the pharmaceutical industry supporting studies in Phase 1 Clinical Pharmacology and Experimental Medicines.

BASIC RESPONSIBILITIES: The Manager, Phase 1 Biostatistics, will be responsible for providing statistical support to clinical pharmacology and Experimental Medicines, including the early studies in humans, proof of activity, Thorough QTc study and parts of Phase II/III studies pertaining to PK, and population PK/PD. This person will provide effective statistical support by using or developing advanced quantitative methodology for the exploration, modeling, analysis, and interpretation of PK and PK/PD data. The incumbent will ensure compliance with appropriate global regulatory requirements.

SPECIFIC DUTIES: Provide statistical input into protocol study design. Selection of statistical method for the analysis of PK, PK/PD and population PK/PD data. Develop Statistical Analysis Plan and perform the statistical analysis accordingly. When appropriate, develop statistical models for the analysis and/or modeling of data. Will assist in the preparation of clinical study report (summary tables, statistical appendices, and text). Will oversee quality, quantity, and performance of CROs when needed. Ensure that studies are conducted in a timely manner and in compliance of all regulatory requirements. Contribute to the interactions with regulatory authorities, as appropriate, for resolving issues relating to biostatistics. Ensure that Department maintains current awareness in the area of expertise; enhance the scientific credibility through contributions to the scientific literature (publications/presentations), through extramural activities and scientifically related interactions with academic and health authorities.

Assumes shared responsibility for summary documents for submission to regulatory agencies (IND’s, NDAs). The position requires an individual with: • M.S. with 3+ years of industry experience in biostatistics and an understanding of the clinical drug development process. • Knowledge of regulatory and standard industrial practices in Biostatistics. • Good knowledge of linear models, including repeated measures analyses and mixed effects models. • Good knowledge of design and methods of analyses for crossover studies. • Good computer skills, including SAS, SPlus, and Nonmem • Excellent communication skills. • Effective team player.

External website http://www.pkrecruiting.com

Contact email address: Guoxiang.Shen@bms.com - 1st Feb 2008 [1378]

Senior PK Scientist in New Jersey:

Position Description: Provide drug metabolism and pharmacokinetics support for Drug Discovery Programs. The major responsibility of the selected candidate will be the investigation of ADME characteristics of drug molecules in support of drug discovery programs. The selected individual will collaborate with a broad group of scientists in the department of Drug Metabolism and Pharmacokinetics (MAP) as well as scientists in the Drug Discovery organization. The successful candidate will lead MAP efforts in support of discovery programs. They will attend all working group and other relevant meetings, suggest and implement strategies and tactics to enable programs to select drug candidates for nomination into development. The candidate will be expected to be involved in research activities and supervise and mentor junior Ph.D and senior associate scientists. They will keep abreast of the literature and will actively pursue opportunities for publications and presentations.

Position Requirement: A Doctorate or equivalent degree in pharmaceutical sciences (such as pharmacokinetics, drug metabolism, biochemistry) with 5-7 years of relevant experience in drug discovery/development arena. Experience and training in pharmacokinetics (required) and biochemical drug disposition concepts and assays (preferred) including; physiological pharmacokinetics, computer simulations and data analyses, pharmacokinetic/pharmacodynamic relationships and experimental design, basic enzymology pathways of drug metabolism, induction and inhibition of drug metabolism, impact of transporters on defining ADME characteristics and metabolite structure elucidation. A working knowledge and previous experience with in vitro drug metabolism/transporter models and in vivo pharmacokinetic studies is highly desirable. Prior experience in pharmaceutical industry is preferred. Excellent interpersonal and communication skills (written and oral) are mandatory to perform in this matrix team environment.

Contact email address: jobs@rigel.com - 30th Jan 2008 [1376]

Bioanalytical Scientist South San Francisco Job Code: GP_0108_02

Description: We are seeking a Bioanalytical Scientist with 3-5 yrs pharmaceutical industry experience in the area of drug analysis.

Requirements: - Must possess extensive experience in the use of LC/MS/MS for the quantization of small molecules in biological matrices in support of drug discovery and development projects and be able to maintain and operate API 3000 LC/MS/MS instruments. - Must possess excellent communication skills, and be able to interact with other members of the department and project teams. - The ideal candidate must have a proven track record in bioanalytical work but would also have training and experience in the areas of pharmacokinetics and drug metabolism.

External website http://www.rigel.com

Contact email address: telder@greylock-recruiting.com - 28th Jan 2008 [1373]

Associate Director of PK/PD

Position Responsibilities: Identify preclinical data (e.g., ADME, pharmacology, toxicology, etc.) needed for product evaluation and design of clinical studies and development plans. Develop detailed preclinical development plans and lead execution of preclinical programs acceptable to regulatory authorities; apply principles of drug development science and regulatory science to build thorough but efficient preclinical development plans. Participate with various internal and external disciplines in the research and development of selected drug products.

Qualifications: PhD in a health sciences discipline with 10 years research experience. Experience with research in multiple therapeutic areas a plus. Excellent scientific writing, communication, presentation, documentation, and computer skills. Experience with application of drug development science (e.g., ADME, PK and PK/PD methods and simulation, statistics, etc.) to streamline drug development required; experience interacting with regulatory authorities desired. Desire to work in cross-functional drug development team environment with all levels of employees and management; ability to lead such teams valued. Ability to work internationally and across multiple corporate sites.

Contact email address: telder@greylock-recruiting.com - 28th Jan 2008 [1372]

Director of Clinical Pharmacology and Pharmacokinetics

Company in California looking for industry experienced clinical pharmacology scientist for director role. This scientist must located and able to work in the United States. Requirements include: MD or PhD with 10+ years of industry experience. Excellent communication skills and previous experience with modeling and simulations work. This position will report into a Senior Director and work on project teams with DMPK, Tox and Pharmacology. Experience writing regulatory documents is essential.

External website http://www.greylock-recruiting.com

Contact email address: telder@greylock-recruiting.com - 24th Jan 2008 [1370]

Clinical Pharmacology

Role Description:

Independently establishes and directs all aspects of clinical pharmacokinetic and pharmacodynamic study design and analysis as well as contributing to the planning of broader strategic objectives.

Primary Responsibilities: Responsible for all clinical pharmacology study design with pharmacokinetic analysis and pharmacodynamic assessment of biological parameters of efficacy. Prepare clinical pharmacology study protocols, analysis plans and clinical reports. Oversee interactions with CROs providing sampling kits, conducting sample and PK analysis, report writing, and will include conducting audits of CRO. Provide presentations to clinical teams and internal program reviews. Operate within clinical teams. Participate on EDC teams focused on IND submission and give input on FIH dose estimation and biomarker development.

Requirements: Acts independently to determine methods and procedures on new assignments May direct the activities of other personnel or have direct supervisory responsibilities. Represents company in R&D efforts at national and international levels Takes leadership role in contributing to scientific literature and conferences and builds scientific respect within the company as reflected by these contributions Represents company in program presentations to both internal and external audiences including scientific conferences and partnerships/alliances Contributes to planning activities, ie department budgets, team goals and/or timelines Oversight of working relationships with external vendors and suppliers Able to act as a functional leader and participate on multiple product teams in a leadership role Ability to lead and develop others through constructive mentoring and positive influence Thought leader; able to rapidly work through issues and obstacles and generate creative solutions Ability to communicate across functions and take the lead in a matrix environment.

Qualifications: PhD (PharmD) or equivalent in Pharmacokinetics, Pharmaceutics or Clinical Pharmacology with at least 5 years experience. Extensive experience in clinical pharmacokinetics and pharmacodynamics applied to PK study design, analysis of results and model development using statistical packages such as WinNonLin, NONMEM and SAS. Experience with bioanalytical methods development and validation conducted by CROs. The candidate will have worked in a cross-functional matrix environment as part of clinical teams. A basic inderstanding of drug-drug interaction and metabolism is expected. Excellent communication skills both written and verbal are essential. Experience with regulatory affairs is a plus. Excellent organizational skills.

Please Contact: T.J. Elder Greylock Recruiting telder@greylock-recruiting.com 617-744-6222

External website http://www.greylock-recruiting.com

Contact email address: recruitment@uk.netgrs.com - 24th Jan 2008 [1369]

Servier Research and Development Ltd is the UK division of the Servier Research Group, which in the short space of 50 years, has developed from a family owned provincial pharmacy to a multinational operation with an internationally acknowledged commitment to research. At the Pharmaceutical Marketing Effectiveness awards Servier UK was acknowledged as the “Pharmaceutical Company of the Year” (<£100 million turnover) in Dec 2005 and won Therapy Franchise Award (cardiovascular portfolio) and was a finalist for “Pharmaceutical Company of the Year” (>£100 million turnover) in Dec 2006.

In line with Servier’s investment in the UK and planned programme of expansion, we now wish to recruit talented PK Modellers to built our Clinical Pharmacokinetic, Modelling and Simulation Group.

“A group that succeeds in research has every chance of succeeding in the world. Research is our mission, it is the foundation of the pharmaceutical industry” Dr Jacques Servier

PK Modellers The successful candidates will be responsible for the design and execution of clinical PK/PD and population PK/PD studies. You will analyse and interpret PK/PD data generated for compounds in early and full development programmes or post marketing.

Summary of Duties: Pre-clinical

Clinical

Qualifications Required:

Servier recognises that a successful working environment is achieved through the cohesion of a friendly, but highly professional team. Servier is also passionately committed to employee development and has an exceptional track record in promoting loyal and committed employees to all levels of management.

In addition to an excellent negotiable salary, we also offer an outstanding benefit package, which includes BUPA, contributory pension scheme, life and permanent health insurance and a generous holiday entitlement.

For further information on current job vacancies please visit our web-site www.servier.co.uk. Alternatively send your CV and covering letter on-line to recruitment@uk.netgrs.com or by post to the Recruitment Advisor, Servier Laboratories Ltd, Rowley, Wexham Springs, Framewood Road, Wexham, Slough, SL3 6PJ, in all cases please quote the appropriate position.

Contact email address: gemick@usachoice.net - 23rd Jan 2008 [1368]

Senior Scientist - Drug Metabolism/Pharmacokinetics New Jersey, U.S.A. Full Time Position

Description:

Qualifications:

Contact email address: telder@greylock-recruiting.com - 23rd Jan 2008 [1367]

Senior Scientist, DMPK/Bioanalytics to be responsible for performing and overseeing all bioanalytical efforts for the quantitative analysis of drugs and metabolites in biological matrices in support of the company’s drug discovery and development efforts.

Responsibilities:

This position requires the ability to develop analytical methodologies, primarily LC-MS/MS based approaches for conducting these assays. Knowledge of the principles of pharmacokinetics is required for modeling and interpretation of pharmacokinetic data. Similarly, strong laboratory skills are required for various sample preparation approaches and the use of mass spectrometry. Good written / oral communication and organizational skills are mandatory as communications across functional lines are required. The ability to interpret PK and TK data to assist in understanding both efficacy and toxicity findings in context with drug exposure data are also necessary. Expertise in the development of rapid LC-MS/MS methods, sample extraction techniques and maintenance of mass spectrometry instrumentation to enhance delivery time of analytical data are also important.

Requirements

Please Contact T.J. Elder at Greylock Recruiting

telder@greylock-recruiting.com

Or call: 617-744-6222

External website http://www.greylock-recruiting.com

Contact email address: vivien.yule@rustonpoole.com - 22nd Jan 2008 [1366]

MAJOR PHARMA … EUROPEAN HQ

Our client, one of the world’s leading healthcare companies, boasts an outstanding reputation for its innovative research and a superb track record in developing and commercialising market-leading products that have delivered notable improvements in patient care and quality of life.

The Company wishes to recruit an experienced, strategically oriented clinical PK scientist, ideally with a background in oncology, to the position of clinical PK/PD Leader Oncology. The role is within the Global Clinical Pharmacology organisation, that supports compounds in Early and Late Development, as well as Marketed Products.

The PK/PD Leader Oncology will take responsibility for following up the clinical PK/PD evaluations of oncology projects working closely together with the Compound Development and Clinical Team in close collaboration with Preclinical PK and Discovery scientists.

The successful candidate will have a PhD or Masters in a relavnt biological sciences discipline; good understanding of strategic drug development, in particular Early Development, and of Clinical Pharmacology’s role in maximising the output of drug development, based on experience gained in pharmaceutical companies or CROs; substantial experience in clinical development, specifically in pharmacokinetic data interpretation, and good understanding of PK/PD modelling, clinical PK and PK/PD study designs;[duplication]. Experience of oncology would be highly valued.

The role necessitates innovative thinking, strategic vision and entrepreneurial leadership; a hands-on approach; excellent interpersonal, communication and networking skills; strong delivery focus, and fluency in English.

This is an exciting opportunity for a PK expert to join one of the world’s most successful healthcare companies and to develop their career within a dynamic, innovative, well resourced environment offering excellent career development prospects.

A competitive remuneration package will be offered including relocation where appropriate.

If you have the right credentials and are interested in exploring one of these exciting roles and working in a stimulating international environment, please email your CV to Vivien Yule at Ruston Poole International plc, Cording House, 34 St. James's Street, London SW1A 1HD. Email: vivien.yule@rustonpoole.com

Contact email address: JanetJarboe@qwest.net - 21st Jan 2008 [1365]

Associate Director, DMPK (Massachusetts)

Requirements:-Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, or related discipline with 5-10 years of industry and/or related ADME/PK experience. -Has an overall understanding of drug research and development. -Experience directing nonclinical ADME/PK. -Extensive knowledge of pharmacokinetic and pharmacodynamic principles. -A thorough knowledge of clinical pharmacology. -Experience in preparation of regulatory submissions. -Experience interacting with regulatory authorities on nonclinical ADME/PK and Clinical -Pharmacology/Pharmacokinetic issues. -Knowledgeable in GLP, ICH and regulatory guidance. -Experience with advanced data analysis skills. -Has an overall understanding of method validation, bioanalytical sample analysis, and various instrumentations (HPLC, LC/MS/MS, GC, etc.). -Knowledgeable of the expertise of CROs and experience in monitoring bioanalytical studies at CROs. -Excellent written and oral communication skills.

Responsibilities and Accountability:-Responsible and accountable of the nonclinical ADME/PK components of the drug development. -Develop nonclinical ADME/PK programs in development stage. -Support toxicology studies, as needed (toxicokinetics, tissue drug levels, tissue enzyme evaluation, etc.). -Assist in studies to support formulation screening.

Pharmacokineticist

Requirements Candidates should have a graduate degree (Ph.D. preferred but not mandatory) with experience using and reporting pharmacokinetic data from relevant and accepted software (e.g., WinNonlin/NONLIN, SAS, NONMEM, S-Plus) as well as modeling pharmacokinetic-, pharmacokinetic/pharmacodynamic and population pharmacokinetics. Experience within the pharmaceutical industry is strongly desired.

Description The successful candidate will be responsible for all aspects of GLP toxicokinetics as well as clinical pharmacokinetic studies including data management, pharmacokinetic modeling, interpretation and presentation of data for a variety of programs. Excellent oral and written communication skills are necessary since the candidate will be responsible for the writing of toxicokinetic reports, related IND sections, Summary documents and final clinical study reports. In addition to working with scientists within Drug Metabolism, the candidate will work closely with others in Clinical, Regulatory, Pharmacology/Toxicology, and Pharmaceutics Departments and provide information and guidance to Discovery, Development Teams and senior management.

Assistant / Associate Director Clinical Pharmacology

Description:This key position in our Clinical Pharmacology department is responsible for:--providing clinical pharmacokinetic (PK) and pharmacodynamic (PD) information needed to make a sophisticated design of clinical pharmacology studies based on advanced PK/PD modeling & simulation including population pharmacokinetic approaches (Pop PK) to project teams for multiple drug development programs from a variety of therapeutic areas, --assisting in preparation of the Clinical Pharmacology development plan, --support clinical study managers across projects, --preparation of PK analysis plan, data analysis and preparation of PK/PD components of study reports, --assisting in preparation of Briefing Documents, INDs and NDAs and representing Clinical Pharmacology to regulatory agencies. --assuring compliance with SOPs, and FDA and ICH guidelines and regulations.

Requirements:PhD or PharmD in Pharmacy or life sciences with extensive training in pharmacokinetics and pharmacodynamics and data analysis, i.e. biostatistics, pharmacometrics. Seven years of Research Data Science or Clinical pharmacology experience or equivalent. Knowledge of global drug development process and ability to design and implement PK/PD and/or Pop PK assessments within an integrated global drug development plan. Experience in providing strategic input to global clinical development plans. Extensive experience in representing Clinical Pharmacology to regulatory agencies.

Clinical Pharmacology/PK/PD /Modeler

Description:The Clinical Pharmacology department in the Research & Development division has opportunities in clinical pharmacokinetics (PK) and pharmacodynamics (PD) on its global project teams, which handle multiple drug development programs in a variety of therapeutic areas. As a member of a team this position designs and prepares protocols for clinical PK/PD studies. If the team member has biostatistics or mathematics expertise they would be called on to design clinical pharmacology studies based on advanced PK/PD modeling & simulation including population pharmacokinetic approaches (Pop PK). Other responsibilities depending on experience level may include project management, study site evaluation, data analysis, report preparation, review and presentation.

Requirements:PhD or PharmD in Pharmacy or life sciences with training in pharmacokinetics and pharmacodynamics or PhD in biostatistics, mathematics, bioengineering, pharmacometrics or related similar area At least four years Industry or post doc experience in Research Data Science or Clinical pharmacology.Knowledge of global drug development process and ability to design and implement PK/PD and/or Pop PK assessments within an integrated global drug development plan required for the advanced level positions.Experience in providing strategic input to global clinical development plans. or experience in representing Clinical Pharmacology to regulatory agencies a definite plus for the experienced candidate.

Director Clinical Pharmacology

Description: Providing clinical pharmacokinetic (PK) and pharmacodynamic (PD) expertise to local and global project teams for multiple drug development programs from a variety of therapeutic areas, Scientific leadership, direction, and management of Clinical Pharmacology, and the development of short- and long-term objectives of Clinical Pharmacology, Supervision of associate/assistant directors, managers, and other staff across projects, Preparation of PK/PD components of Briefing Documents, INDs and NDAs and representing Clinical Pharmacology to regulatory agencies.

Requirements: PhD or equivalent with extensive training in pharmacokinetics and pharmacodynamics and data analysis. Ten years of Phase I clinical trial experience or equivalent. Knowledge of global drug development processes and ability to design and implement Clinical Pharmacology development plans within an integrated global drug development plan. Experience in providing strategic input to global clinical development plans. Extensive experience in representing Clinical Pharmacology to regulatory agencies. Established leadership skills. Five years experience in people management. Proven communication skills.

Associate Director / Clinical Team Leader, Clinical Pharmacology

Provide effective, timely, efficient, and supportive leadership for direct reports and assigned contract personnel. Removes roadblocks, facilitates timely feedback, assesses progress toward timeline, provides technical expertise and direction if requested, and develops resources to maximize potential Actively develops the management and scientific skills of Clinical Pharmacology direct reports and assigned contract personnel on an ongoing basis. Work cooperatively with Clinical Pharmacology (CP) personnel, non-departmental company personnel, and outside contractors to achieve Clinical Pharmacology Unit, PKDM department, R and D department, and company goals and objectives. Provide scientific expertise for the planning, design, data analysis and interpretation, and reporting of clinical PK/PD studies and regulatory dossiers to support the clinical development and registration of lead candidates and post-marketed products. Prepares and maintains clinical pharmacology development plans and budgets for assigned projects and studies and ensures the team activities meet the aims, goals, and specified objectives. Provide support to senior staff in developing plans and study designs for effective and efficient conduct of Clinical Pharmacology studies. Submits and administers employee performance standards and actively develops personnel within the team. Provides timely and quality documents (i.e., protocols, clinical study reports (Scars), technical reports (TRs) and Common Technical Documents (CTDs) to support global registrations on designated projects. Represents Clinical Pharmacology at various clinical meetings and project team meetings.

Principle Responsibilities: Responsible for ensuring that the clinical and pharmacokinetic operations of the team are conducted in compliance with company PKDM standard practices, GCPs, SOPs, FDA and ICH guidances and regulations and Alcon R&D objectives. Ensures that the team prepares timely and quality documents for regulatory submissions/responses for assigned project activities. Provide effective and timely mentoring and support for subordinates. Develop budget for assigned studies and provide these budgets to the CP unit head. Manage studies to stay within approved budget constraints. Additional (enhancing) skills: Experience in pharmacokinetic and pharmacodynamic data analysis and modeling and simulation. Familiarity with relevant company SOPs and document management systems Good knowledge of GCP requirements. Familiarity with FDA and ICH regulatory guidance documents related to PK, PD, and clinical pharmacology. Excellent written and oral communication skills.

Sr. Manager Clinical Pharmacology

Description: Responsible for providing clinical pharmacokinetic (PK) and pharmacodynamic (PD) expertise to LWT and GWT for multiple drug development programs from a variety of therapeutic areas. Responsible for clinical PK/PD study design, protocol preparation, implementation, data analysis and study report preparation. Responsible for managing the activities of personnel associated with conduct of Clinical PK/PD studies and assurance of compliance with SOPs, and FDA and ICH regulations. Responsible for preparation of PK/PD components of Briefing Documents, INDs and NDAs and representing Clinical Pharmacology to regulatory agencies.

Requirements: PhD, PharmD, MS, BS in Pharmacy or life sciences with extensive training in pharmacokinetics and pharmacodynamics and data analysis. Seven years of Phase I clinical trial experience or equivalent. Knowledge of Clinical Research Organization industry for clinical trials. Knowledge of global drug development process and ability to design and implement Clinical Pharmacology development plans within an integrated global drug development plan. Experience in providing strategic input to global clinical development plans. Extensive experience in representing Clinical Pharmacology to regulatory agencies. Established leadership skills.

Contact email address: sbell@encoreexecutives.com - 21st Jan 2008 [1363]

Associate Pharmacokineticist (CRO Experience a must)

Mississauga Location

Qualifications M.Sc. in Pharmacokinetics and experience in design and conduct of bioavailability and bioequivalence studies. User-level knowledge of pharmacokinetic software (e.g. WinNonlin®, Kinetica®, etc.) and statistical software (SAS®). 2-3 years related experience. Good communication skills including good English verbal and written skills. Good interpersonal skills. Ability to work both independently and as a team member.

Duties and Responsibilities: Responsible for developing, writing, implementing and maintaining Standard Operating Procedures (SOPs) related to pharmacokinetics, biostatistics and report writing activities in co-operation with the Vice President Scientific Affairs and the Director, Quality Assurance. Responsible for acquiring and maintaining knowledge of national and international guidelines linked to bioavailability and bioequivalence studies. Ensure timely delivery of accurate study reports to Pharma Medica Research Inc. (PMRI) clients. Assist in the analyses of pharmacokinetic and bioequivalence studies, as required. Assist in the preparation of study designs in a timely manner to assure PMRI’s prompt response to clients’ requests for study quotations. Review study protocols for scientific accuracy, correct selection of study designs and compliance with TPD-Canada, FDA-US and/or EC-Europe guidelines.

NB: Immigration Services not available.

Regards, Steve Bell

Contact email address: franca.pugnaghi@aptuit.com - 18th Jan 2008 [1361]

Aptuit preclinical provides a range of services to the pharmaceutical and biotechnology industry to facilitate the efficient development of new chemical entities. DMPK (drug metabolism and pharmacokinetics) is an integral part of this service, assessing the effect of the body to the new chemical entities. The DMPK facility conducts research in an environment that ensures the highest possible welfare standards, exceeding legislative requirements and driving forward innovation and best practice.

Responsible for:

Requirements: Interactions: Please email your CV/Resume to franca.pugnaghi@aptuit.com or call Franca Pugnaghi at 0044 (0) 131 451 2308 Franca Pugnaghi Senior Manager, DMPK +44(0) 131 451 2308 office +44(0) 131 451 2464 fax www.aptuit.com
Contact email address: gemick@usachoice.net - 16th Jan 2008 [1360]

Job Description: Clinical PK * Several Position Available – Entry Level thru Principal Scientist Level determined by experience and expertise

Job Location: Jersey City, New Jersey

JOB DUTIES: (This description does not have to be a perfect fit) * Design and conduct pharmacokinetics studies. * Analyze and interpret pharmacokinetic data. * Prepare regulatory documents, including studies reports, briefing books, NDA submissions, and responses for project teams. * Act as departmental representative for project teams. * Present pharmacokinetic data to project teams and supervisors. * Review documents prepared by other project team members. * Work with Winnonlin to identify covariates including age, gender, life/kidney function to determine pharmacokinetics of various drugs that are currently being developed.

JOB REQUIREMENTS: PHD IN PHARMACEUTICAL SCIENCES. EXPERIENCE: 12 months research experience. * Experience must include data analysis and modeling and Winnonlining to identify covalates including age, gender, liver/kidney function, to determine pharmacokinetics of various drugs that are currently being developed, and effects of various covariates. * Must also have experience with clinical pharmacokinectics and statistics (can be gained through education or experience)

Contact email address: gemick@usachoice.net - 16th Jan 2008 [1359]

Associate Director, DMPK

Beverly , Massachusetts

--- Description ---

Requirements:

Responsibilities and Accountability:

Contact email address: mike@pharmaes.com - 15th Jan 2008 [1358]

Our client, based in the Philly area and ranked in the top 15 biopharmaceutical companies worldwide, is built on a strategic platform focused in select therapeutic areas of attention deficit and hyperactivity disorder (ADHD), gastrointestinal (GI), renal diseases and human genetic therapies. Due to their rapid growth, they are seeking to fill two newly created positions:

Director/Senior Director, Clinical Pharmacology

Responsibilities: Providing clinical pharmacokinetic (PK) and pharmacodynamic (PD) expertise to local and global project teams for multiple drug development programs from a variety of therapeutic areas. Scientific leadership, direction, and management of Clinical Pharmacology, and the development of short- and long-term objectives of Clinical Pharmacology. Supervision of associate/assistant directors, managers, and other staff across projects. Preparation of PK/PD components of Briefing Documents, INDs and NDAs and representing Clinical Pharmacology to regulatory agencies. Requirements: PhD or equivalent with extensive training in pharmacokinetics and pharmacodynamics and data analysis. Ten years of Phase I clinical trial experience or equivalent. Knowledge of global drug development processes and ability to design and implement Clinical Pharmacology development plans within an integrated global drug development plan. Experience in providing strategic input to global clinical development plans. Extensive experience in representing Clinical Pharmacology to regulatory agencies. Established leadership skills. Five years experience in people management. Proven communication skills.

Competitive base salary, bonus, stock options, Long Term Incentive Package, etc. Full company sponsored relocation package available. Qualified candidates should submit their CV's to Mike Aloisi at: Michael R. Aloisi Principal/Director, Executive Search Operations Pharma ES, L.L.C. Pharmaceutical Executive Staffing Office: (914) 630-1109 Fax: (914) 381-0627 Mobile: (914) 406-5273 E-mail: mike@pharmaes.com

Contact email address: andrew.smugeresky@pfizer.com - 10th Jan 2008 [1357]

PK/PD Modeler - Pfizer La Jolla

Imagine a career that touches the lives of people everywhere. Imagine an opportunity to reach beyond your area of expertise to make an impact on something greater than the bottom line. Imagine playing a key role in some of the most critical issues facing healthcare today. This is your career at Pfizer – a career unlike any other.

This position will be responsible for collaborating within the PDM PK/PD function to establish PK/PD approaches as a core competency for PDM in alignment with PGRD PK/PD best practices. Modeling using NONMEM and/or other appropriate simulation/data visualization tools is expected. The candidate will design, plan, execute, analyze, and interpret PK/PD studies in collaboration with & support of other disciplines in PDM and across Pfizer Global R&D Discovery & clinical PK/PD lines (among others) to build predictive and translatable preclinical PK/PD models. The candidate will use these models to enable Discovery projects to make appropriate predictions of clinical dose regimens based on the NCE’s PK/PD characteristics and desired therapeutic index. A primary responsibility will be the technical application of practical PK/PD modeling to preclinical in vivo efficacy models/data in support of drug discovery programs. The candidate will also be expected to influence PDM and partner line scientists to optimize in vivo efficacy models to improve the quality, productiveness, & translatability of PK/PD models/data, where appropriate. Translating knowledge of emerging literature and science in the PK/PD area into new and innovative methods and applying those methods to support Discovery teams will be expected. Outstanding oral/written communication skills are mandatory, as well as a proven record of building strong collaborations and effective interfaces within PDM and across research lines.

MINIMUM: R6: Ph.D. with 5-7 years, M.S. with 8-10 years, or B.S. with 11-13 years experience in pharmacokinetics, pharmaceutics, or a related field including previous experience in PK/PD or ADME/PK modeling of NCEs/drugs R7: Ph.D. with >7 years, M.S. with >10 years, or B.S. with >13 years experience in pharmacokinetics, pharmaceutics, or a related field including previous experience in PK/PD or ADME/PK modeling of NCEs/drugs

DESIRABLE: R6: M.S. or Ph.D. in Pharmaceutics or related field with >7 years previous experience in PDM or related discipline; specific academic training though graduate education, post-doctoral fellowship, or sabbatical in PK/PD modeling; Specific training in numerical and statistical aspects of analysis, modeling and simulation of biomedical data. R7: M.S. or Ph.D. in Pharmaceutics or related field with >9 years previous experience representing PDM discipline; specific academic training though graduate education, post-doctoral fellowship, or sabbatical in PK/PD modeling; Specific training in numerical and statistical aspects of analysis, modeling and simulation of biomedical data

WORK EXPERIENCE/SKILLS: MINIMUM: - Proficiency working with databases, web based applications and other information technology tools. - Expert knowledge of ADME, PK, and PK/PD principles and sound understanding of the role of contemporary PDM science in drug discovery and development - Demonstrated track record of impact in using PK/PD knowledge to influence project teams to advance drug discovery/development projects. Proven ability to predict exposure-response relationships for moderately complex pharmacology and exposure-response relationships. - At least 3 years experience as preclinical PK/PD modeler in a drug-discovery environment. - Expert understanding of PKPD theory and principles; proficiency with of NONMEM or equivalent PK/PD software package (e.g. Splus, SAS) - Proven record of developing and implementing new PK/PD models with existing software packages, including advanced understanding of mathematical and statistical concepts related to PK/PD. - Proven record of effectively distilling outcomes of PK/PD analyses into information that has been used by project teams to make decisions regarding PK/PD related attrition risks - Proven record of innovation and implementation of scientific and technological developments in the area of PK/PD modeling - Ability to partner with IT group to support software/hardware applications enabling PK/PD - Superior interpersonal relationship skills with a proven ability to drive PK/PD strategies/understanding at the project team and TA indication level to manage exposure-response attrition risks. - Understands what PK/PD studies will provide the highest impact in support of project goals; balances the rigor of these studies against resource needs to address specific PK/PD attrition risks and influences team to adopt strategies consistent with this understanding - Proven record of developing effective partnerships across disciplines and in a matrix environment - Superior oral/written communication skills

DESIRABLE: Proven track record of successfully working in the PDM discipline as a PK/PD expert impacting/influencing drug discovery/development teams and/or PDM project leader/representatives For immediate consideration, email your resume to andrew.smugeresky@pfizer.com

External website http://www.pfizer.com/careers/

Contact email address: todd.upham@pfizer.com - 10th Jan 2008 [1356]

PK/PD Leader - Pfizer La Jolla

Imagine a career that touches the lives of people everywhere. Imagine an opportunity to reach beyond your area of expertise to make an impact on something greater than the bottom line. Imagine playing a key role in some of the most critical issues facing healthcare today. This is your career at Pfizer – a career unlike any other.

The PK/PD leader will lead the establishment of PK/PD approaches as a core competency for preclinical research in line with the PGRD PK/PD best practice recommendations. This role will include collaborating with Therapeutic Area Leadership in Pharmacokinetics, Dynamics & Metabolism (PDM), Discovery Biology, the clinical PK/PD group and others to assure that translatable preclinical PK/PD models are developed and implemented at the site and on a global basis. This individual will provide strategic leadership at the site and globally in identifying, implementing and maintaining state of the art data acquisition, modeling, reporting, and archiving environment. Modeling will be conducted using NONMEM and other appropriate simulation and data visualization tools. These models will be used to enable Discovery projects to make predictions for appropriate clinical dosage regimens on the basis of compounds’ PK/PD characteristics and desired therapeutic indices. A key aspect of this role will be assure that state of the art experimental and data analysis/reporting methods are implemented on a global basis, through active participation as a member of the PDM Global PK/PD Working Group. This individual will also serve as the PDM representative on the Translational Pharmacology Team at the site, assuring cross functional alignment and coordinated support of the application of PK/PD methods from early Discovery to clinical Proof of Concept. Establishes network with external PKPD experts and centers of excellence. Serves in PDM as primary reviewer of Translational Research Plans across the portfolio of projects. Principal liaison with site Discovery Biology, Clinical PK/PD, Biometrics, and IT Departments to assure that optimal experimental, modeling and simulation approaches are applied. Serves as site PDM representative to the PDM Global PK/PD Working Group, and other global teams, as appropriate. Supervises site PK/PD Modeling group in planning, performing and reporting PK/PD analyses to support preclinical programs. Identifies and maintains external contacts and collaborations to assure that state of the art methodologies are applied to Pfizer projects. Liaises with Discovery Biology Leadership to facilitate the development and modification of in vivo models to support the efficient generation of translatable PK/PD data. Liaises with the Clinical PK/PD group Leadership, including the Pharmacometrics network to facilitate linking of preclinical and clinical PK/PD analysis in programs where such data is available and to assure optimal translation of preclinical to clinical PK/PD models. Regularly contributes to the literature and external scientific presentations in the PK/PD area and encourage implementation of new methodology/technology.

EDUCATIONAL BACKGROUND: MINIMUM: PhD (or equivalent experience) in the area of PK/PD, Pharmacology or Statistics

WORK EXPERIENCE/SKILLS: MINIMUM: 5-10 years hands-on experience as PK/PD modeler; specific training in numerical and statistical aspects of analysis. Modeling and simulation of biomedical data. PK/PD experience obtained in a drug discovery environment. Experience with population approaches in PK and/or PK/PD.

DESIRABLE: Academic level teaching experience and significant experience presenting to external multi-disciplinary scientific audiences. Externally and internally recognized expert in the area of PK/PD modeling with a solid publication record.

Email resume to todd.upham@pfizer.com

External website http://www.pfizer.com/careers/

Contact email address: pbowser@brunelmultec.ca - 10th Jan 2008 [1355]

My client is a biotechnology company in Vancouver, BC searching for leadership in the position of Director, Preclinical R&D.

The Director will lead early to late stage pre-clinical development projects, working closely with the Vice President, Preclinical to meet program goals and objectives, and provide technical guidance, remove barriers, and facilitating increased speed to market of new products.

The successful candidate will take management responsibility for a small but effective development team, and should be an experienced facilitator, able to work with scientists to improve group communications and motivate teamwork across projects.

You should be an experienced PK/PD scientist, able to contribute to our understanding of drug tissue kinetics and toxicokinetics. Your experience in PK/PD modeling will help develop strategies for pharmacokinetics specifically novel approaches and simulations.

Requirements:

Vancouver is consistently ranked as one of the three most livable cities in the world. Excellent salary commensurate with experience. Relocation expenses will be paid. Please send your resume in confidence to pbowser@brunelmultec.ca ; qualified candidates will be contacted.

Contact email address: contcsc@optonline.net - 9th Jan 2008 [1354]

Responsibilities:

Responsibile for proposal preparation and for the scheduling, performance, monitoring, evaluation, reporting and financial oversight of ADME studies performed in a contract research organization setting. (no surgery required)

Develop and review protocols, data and interface in compliance with specifications and regulatory guidelines.

Responsible for oversight in training and professional development of the study team.

Requirements:

PhD (3+ years industry exp.) in a relevant field or a BS/MS degree (6-9 years industry exp.) in a relevant field and 3+ years of Industry/CRO experience in ADME and INVIVO drug metabolism.

Experience conducting and directing in vivo drug disposition studies with radiolabeled and nonradiolabeled compounds in rodents, dogs and primates is required.

Experience conducting in vitro drug metabolism studies preferred.

Contact email address: terry@tompkinsassociates.com - 7th Jan 2008 [1353]

Sr. Scientist II / III – Research Pharmacokinetics

Established company with 5-billion in revenue. Great benefit package and $100k-plus salary

Responsibilities * Carry out/direct preclinical pharmacokinetic experiments to ascertain biodistribution of therapeutic agent and its dependence on drug structure and/or formulation design * Conduct ocular bioavailability screening of compounds during hit–to-lead and lead-optimization stages * Correlate in vivo results with in vitro evaluations * Supervise personnel * Provide preclinical pharmacokinetic data in support of Discovery, Research, Drug Delivery, and project teams

Qualifications * Experience preparing INDs or NDAs * Pre-clinical PHARMACOKINETICS/drug metabolism experience * Doctorate (Ph.D.) degree within the scientific/technical discipline (preferably in Pharmacology, PHARMACOKINETICS, or Biochemistry) with two or more years of applicable experience

Contact email address: jchapman@haallc.com - 6th Jan 2008 [1351]

Description: This individual will be responsible for assisting with Clinical Pharmacology studies and may serve as the key person in the Clinical Pharmacology department for one of the companys program. Specifically, he/she will analyze PK/PD data from clinical studies (Phase I-IV), using NONMEM, WinNonlin, SPLUS or SAS, and will write reports for regulatory submissions; provide scientific input for Clinical Protocols, clinical development plans, Investigator Brochures, and the Clinical Pharmacology section of INDs and NDAs; and interact with contract research organizations (CROs). Also, he/she will be expected to independently develop clinical pharmacology analysis plans, evaluate clinical trial data using advanced exploratory data analyses techniques, and perform clinical trial simulations and apply novel pharmacometric principles to assigned studies. Supervision of department staff may be required.

Requires a PhD in Pharmaceutics, Clinical Pharmacology, Biostatistics, Chemical Engineering or Mathematical Biology, plus 4-7 years in the pharmaceutical industry or within a regulatory agency. Candidates with more experience will be considered for the Associate Director position. All candidates must have substantial knowledge of the requirements for the design, conduct, analysis, and report writing for regulatory submissions, in-depth understanding of drug metabolism and PK/PD principles, experience working with SPLUS or SAS and NONMEM, and an understanding of clinical trial simulation and integration of PK/PD modeling in drug development. Must have good verbal and written communication skills.

All interested parties please send your updated CV to jchapman@haallc.com and begin your year with the career you have always wanted.

Contact email address: chon@cc.nih.gov - 3rd Jan 2008 [1349]

This two-year fellowship program provides specialized skills in clinical pharmacokinetic/pharmacogenomic study design, methodology, and data analysis and presentation. The fellow will collaborate in on ongoing drug metabolism/transport investigations in addition to developing and initiating individual research projects. The program will provide ample opportunity for the fellow to gain expertise in pharmacokinetic data analysis (using software programs such as WinNonlin; SAAM II etc.), statistical analysis, scientific writing, and grantsmanship. Opportunity to become skilled in drug assay procedures will be provided, as will opportunities for advanced coursework in pharmacokinetics, statistics, pharmacology, and genetics. The fellow will also attend scientific meetings (typically one per year) where they will present preliminary scientific data in abstract form; manuscript preparation and publication will follow.

Entrance requirements: A Doctor of Pharmacy or other advanced degree A strong interest and basic skills in clinical pharmacokinetics and pharmacogenetics

Salary and benefits: Competitive salary Most benefits associated with federal government employment

Application and Interview Procedure: On-site interview and presentation required. Interested candidates should contact:

Christine Yuen-Yi Hon, Pharm.D., BCOP Clinical Pharmacokinetics Research Laboratory National Institutes of Health Bldg 10, Rm 1N257 10 Center Drive Bethesda, MD 20892 Phone: 301-496-0967 email: chon@cc.nih.gov

External website http://clinicalcenter.nih.gov/phar/

Contact email address: mike@pharmaes.com - 19th Dec 2007 [1347]

Our client, a worldwide leading global biotechnology company based in Massachusetts with a number of marketed products and an excellent pipeline focused on viral diseases, inflammation, autoimmune diseases, cancer, pain and bacterial infection is seeking a number of high profile Clinical Pharmacology positions due to their rapid growth and expansion.

DIRECTOR(S), CLINICAL PHARMACOLOGY POSITION SUMMARY: Ensure effective, scientifically sound and consistent design and conduct of PK/PD data from clinical studies (Phase I-IV), including first in human, drug interaction, special population, food effect and other clinical pharmacology studies.

DUTIES AND RESPONSIBILITIES: The position represents the Clinical Pharmacology function on integrated project teams and requires close collaboration with preclinical discovery and operations. Duties include analysis, interpretation and reporting of PK/PD data and results. This person will be required to provide scientific input for Clinical Protocols, clinical development plans, Investigator Brochures, and the Clinical Pharmacology section of INDs and NDAs and interact with contract research organizations (CROs). This individual will analyze PK/PD data from clinical studies (Phase I-IV), using NONMEM, WinNonlin, SPLUS or SAS, and will write reports for regulatory submissions. They will also be expected to independently develop clinical pharmacology analysis plans, evaluate clinical trial data using advanced exploratory data analyses techniques, and perform clinical trial simulations and apply novel pharmacometric principles to assigned studies. Supervision of department staff may also be required.

QUALIFICATIONS: Pharmaceutics, Pharmacokinetics, Pharmacology or related field or PharmD. Must have relevant experience and possess project work experience with all aspects of PK/PD using noncompartmental and modeling techniques. PK/PD related software, such as WinNonlin, NONMEM, Adapt, or S-Plus. Familiarity with ICH, FDA and GCP guidelines governing clinical trial design and conduct. All candidates must have substantial knowledge of the requirements for the design, conduct, analysis, and report writing for regulatory submissions, in-depth understanding of drug metabolism and PK/PD principles. In addition, applicants must have a strong understanding of clinical trial simulation and integration of PK/PD modeling in drug development and have excellent verbal and written communication skills.

Competitive base salary, bonus, stock options, Lomg Term Incentive Package, etc. Full company sponsored relocation package available.

Qualified candidates should submit their CV's to Mike Aloisi at: Michael R. Aloisi Principal/Director, Executive Search Operations Pharma ES, L.L.C. Pharmaceutical Executive Staffing Office: (914) 630-1109 Fax: (914) 381-0627 Mobile: (914) 406-5273 E-mail: mike@pharmaes.com

Contact email address: mike@pharmaes.com - 19th Dec 2007 [1346]

Director/Sr. Director Clinical Pharmacokinetics

Reporting to the VP, Global Clinical Pharmacology, the Clinical Pharmacokinetics Director will be responsible for providing clinical PK/PD support to project teams and will provide clinical PK/PD expertise to support t he development, registration and commercialization of our products.

Responsibilities will include:

Qualifications:

This position is based in the Chicago area. Competitive base salary, bonus, stock options, Long Term Incentive Package, etc. Full company relocation available.

Qualified candidates should submit CV to: Michael R. Aloisi Principal/Director, Executive Search Operations Pharma ES, L.L.C. Pharmaceutical Executive Staffing Office: (914) 630-1109 Fax: (914) 381-0627 Mobile: (914) 406-5273 E-mail: mike@pharmaes.com

Contact email address: kendall@bluespeed.net - 18th Dec 2007 [1345]

Modeling & Simulation Consultant for Growing Publicly Traded Client

This is a retained search in which we are seeking a Senior Scientist with the ability to execute complex modeling and simulation projects. We also are looking for a individual with consulting skills and mentoring and leadership capabilities.

Bluespeed Technology, Inc. is committed to streamlining the process of seeking out the best talent in the Life Sciences arena for innovative, cutting-edge, global organizations. In our synergized team environment, we build long-term relationships by thoroughly understanding the specific needs of both our clients and applicants. For this particular client we are seeking an experienced Modeling & Simulation Scientist to provide expertise and leadership in the area of Pharmacokinetics/Pharmacodynamics Modeling Services.

What you will get to do: This is a position that will afford an individual the opportunity to: be responsible for all aspects of multiple projects which will include but not be limitted to: Defining key trial design issues Analysis PK/PD Modeling Simulation Interpretation Presentation of results Leadership This position will also provide a chance to flex your expertise in: Scientific Techniques: You will be formulating complex problems, approaches and models. You will be identifying issues and results on complex projects with minimal to no direction. You will be synthesizing fundamental and secondary insights with decreasing assistance. Extensive use of modeling software - nonlin/NONMEM/SAS Communication: You will structure and prepare complex documents with decreasing supervision. You will be concieving and managing project-level communications with clients and within the firm. You should be comfortable in delivering complex presentations clearly. You will be able to lead effective large meetings. If all of this sounds like something you have done and would like to be a part of, please send a word version of your resume to Bluespeed’s sourcing director eric@bluespeed.net Please send it ATTENTION: Senior PK/PD Modeling Consultant

All qualified candidates can expect to have a detailed conversation with Kendall Messner, Bluespeed’s Senior Managing Partner regarding their background, desires and the opportunity. He will be interested in hearing more about the accomplishments noted on your resume, as well as your future aspirations, salary requirements and other particulars. If “Top Fitment” is determined, Bluespeed then will provide you with detailed information on the opportunity and Client Company, complete with a job description, white papers, websites and any additional information we may have. Next, we will work with you to create a compelling presentation of your abilities and desires to submit to our client. Finally - with our Managing Partner`s approval and your blessing - we will submit the presentation as an official introduction to our client. Thanks for entertaining this exclusive opportunity through Bluespeed Technology Inc.

External website http://www.bluespeed.net

Contact email address: jchapman@haallc.com - 18th Dec 2007 [1344]

You will perform the following functions in this key role:

All interested please send CV to jchapman@haallc.com , and have a great Holiday Season.
Contact email address: gemick@usachoice.net - 10th Dec 2007 [1343]

Associate Director–Clinical Pharmacology Functional Area: Research and Non-Clinical Development State: Delaware Department: Clinical Pharmacology

Responsibilities: The Associate Director, Clinical Pharmacology is involved in all clinical phases of the product development and primarily in program design to Proof of Principle and design of the Clinical Pharmacology package through registration and commercialization, including PK and PD-design of late phase confirmatory trials. In this role, you will provide specialist guidance and direction to project teams, senior leaders, and other colleagues to ensure optimal management of high-impact project opportunities and risks. You will lead development of consensus among diverse scientific, technical, and business experts (often at the global level) so as to ensure scientific quality and timely, cost-effective project delivery.

Major Responsibilities:

Qualifications

Contact email address: hr@hessjobs.com - 7th Dec 2007 [1342]

We are recuiting for a Senior Bioanalytical Scientist for a Canadian client as follows:

Bioanalytical Scientist with expertise in mass spectrometry LC/MS/MS to carry out non GLP new method development - drug discovery bioanalysis, candidate selection and optimization.

REQUIREMENTS: Min M.Sc. or Ph.D. in Biochemistry, Pharmacology, Bioanalytical Chemistry, or related. Strong bioanalytical background in LC-MS/MS drug analysis, sample processing, method development, operations. Must be able to mentor and Troubleshoot. ADMET measurements, PK determinations. 7 to 10 years' bioanalytical background. Drug discovery R&D very important. Excellent interpersonal, communication skills, including interfacing with clients.

RESPONSIBILITIES: Lead/ supervise/ mentor small group of scientists/ technicians. Develop new test procedures for new drug candidates - non GLP type analyses. Multitask in terms of large variety of bioanalytical studies and related analysis and reporting. Should be comfortable interacting with clients.

Please contact: Paula Strasberg, Ph.D. Search consultant 416 447 3355 hr@hessjobs.com

External website http://www.hessjobs.com

Contact email address: kvenisnik@talentwave.com - 21st Nov 2007 [1340]

ASSOCIATE DIRECTOR or MANAGER, CLINICAL PHARMACOLOGY, outside of Philadelphia, PA, for our client, who offers a comprehensive range of services covering essentially every phase of clinical pharmaceutical development on a global basis.

INTRODUCTION This is the opportunity to join a top three CRO with a reputation for excellence, personal growth and diversity of projects. They have global reach but maintain a small company atmosphere where their employees are valued and the leadership team works toward a common vision.

DESCRIPTION The Associate Director of Clinical Pharmacology will supervise the department responsible for development, analysis, and presentation of pharmacokinetic, pharmacodynamic, and biostatistical data from Phase I clinical trials. S/he will develop PK/PD and statistical analysis plans for assigned clinical trials. S/he will review clinical study reports for accuracy and completeness. S/he will participate in proposal meetings with potential clients and present clinical research capabilities. S/he will establish and manager priorities for multiple client projects. S/he will interact with clients and internal team on all aspects of design and analysis for Phase I Clinical Pharmacology trials.

REQUIREMENTS The ideal candidate will have a minimum of a PharmD or Ph.D. complemented by at least five years experience in clinical pharmacology. In addition, this position may be filled at a lower level for a candidate with 1-3 years of clinical pharmacology experience. S/he must be proficient with WinNonlin and other software associated with analysis of study data. S/he must have excellent verbal and written communication skills.

LOCATION This is an office based position located outside of Philadelphia, PA. Relocation assistance may be available for qualified candidates.

COMPENSATION Compensation is competitive and includes a base salary to $125K as well as a comprehensive benefits package including 3 weeks of Paid Time Off, a 401K program, and a profit sharing plan.

Katy Venisnik, Ph.D. Principal Recruiter TalentWave http://www.talentwave.com (310) 325-7250 (direct) (866) 441-4554 (toll-free) CONNECT TO ME ON LINKEDIN http://www.linkedin.com TalentWave was founded by industry veterans, Emily Nelson and Jim Trattner, who have built a team of dynamic talent agents committed to assisting science and technology companies build world-class, high performance, thinking teams. TalentWave surfaces senior contributors in science, technology, sales and marketing who are only rumored to exist. Anyone interested may contact me directly at kvenisnik@talentwave.com or toll-free at (866) 441-4554.

External website http://www.talentwave.com/

Contact email address: kerry@kobsolutions.com - 19th Nov 2007 [1339]

NC -- Associate Director of Bioanalytical

Responsibilities:

Requirements: Ph.D. in Analytical Chemistry or related discipline with more than 10 years of postdoctoral and industrial bioanalytical and DMPK experience; a solid background in qualitative and quantitative mass spectrometry, especially quantitative bioanalysis and structural elucidation of metabolites in biological matrices using LC-MS/MS; working knowledge in pharmacokinetics and drug metabolism, including PK parameter calculation and various DMPK assays. Prior experience preparing reports and summaries for IND/NDA submissions.

Please contact Kerry Boehner of KOB Solutions, Inc. at 412-833-8710 or via email at kerry@kobsolutions.com -- we look forward to working with you!

External website http://www.kobsolutions.com/

Contact email address: kristy@jones-ingham.com - 15th Nov 2007 [1334]

Are you a PK/PD Scientist with good business experience or a product marketing background? My client in Research Triangle Park North Carolina is looking for a Product Marketing Manager for its suite of PK/PD analysis products.

Job Objective: The Product Manager will be responsible for establishing and executing the strategic vision for an assigned product suite. The Product Manager will also serve as the internal and external evangelist for the product offering, partnering internally with sales, marketing communications and engineering to support market definition, competitive analysis, business plan definition, product strategy and strategic partnerships.

ESSENTIAL RESPONSIBILITIES: Manages the entire product line life cycle from strategic planning to tactical activities Specifies market requirements for current and future products by conducting market research supported by on-going visits to customers and non-customers Drives solution sets across development teams (primarily Development/Engineering, and Marketing Communications) through market requirements, product contract, and positioning. Develops and implements a company-wide go-to-market plan, working with all departments to execute. Analyzing potential partner relationships for products

QUALIFICATIONS: Education, Experience, Training, and Knowledge: MBA (with technical B.S.) or Masters of Science At least 5 years of experience in product marketing Experience in software development life cycle Experience in leading new product definition and successful identification of strategic partnering opportunities Experience in marketing products or solutions to life sciences companies preferred Skills & Abilities: Ability to create and maintain successful internal and external relationships by way of superior communication skills Excellent presentation skills that are effective with internal and external audiences Ability to combine business and technical knowledge and translate a product's strategic vision from conception to market Ability to deeply understand market and client needs and facilitate acceptance and engagement of internal stakeholders to enable driving product to market Ability to understand technical issues, development roadmaps and product release requirements that impact product releases Ability to maintain a strong external market big-picture vision for both product and company strategy, finding innovative solutions for a broader market and understanding internal resources.

Contact email address: replies@sevensearch.co.uk - 14th Nov 2007 [1333]

Role is for a Biometrics Officer within a very successful and fast moving Generic Pharma Company Role is to be based in the UK, in or around London. Looking for 2+ years experience in Pharmacokinetics and a desire to experience the pace and variety you can only get in a Generic Manufacturer. We believe this individual may have only 2-3 years experience in the pharma industry. Due to the specifics of the role we need an individual with experience working with the UK and European regulatory authorities, and already residing in the UK. Please Quote SSL0042 in correspondence

Responsibilities: To have a current knowledge of all relevant guidelines and directives. To organise bioequivalence studies to support Marketing Authorisation applications for the European market. To review the pharmacokinetics of the product in question and prepare a summary of the pertinent points. To obtain quotes from appropriate Contract Research Organisations for each study. To liaise with the development site to obtain relevant documentation and samples. To order brand samples required for the bioequivalence studies and to maintain a log of the samples held at the company for bioequivalence study purposes. To provide documents to the Contract Research Organisation to support a CTA for each study. To review and modify (if necessary) the protocol for each study to ensure it is appropriate to the product in question. To act as Sponsor’s contact throughout the duration of each study. To monitor studies where required. To resolve any issues arising during the studies in a timely manner. To review the final study report (if necessary) and arrange for copies to be provided to all interested parties. To ensure bioequivalence studies are conducted in line with GCP, GLP and current guidelines. To perform audits of new Contract Research Organisations as required. To provide technical support to the Regulatory Affairs department with respect to Competent Authority questions and clinical and pharmacokinetic issues. To log, follow-up (if required) and process adverse drug reactions (ADRs) received in the appropriate manner. To provide information and updates to the Pharmacovigilance Manager regularly and upon request. To undertake other activities as requested by the Pharmacovigilance Manager and Head of Regulatory Affairs.

Contact email address: shula@fforde-management.com - 12th Nov 2007 [1329]

Director / Associate Director PK/PD Ref: FW 00183 Our client, a premier global biotech, is committed to the advancement of science that will enable people to live longer and healthier lives with a focus on developing products that are designed to prevent or treat infectious diseases, cancer and inflammatory diseases. They are seeking an experienced and well qualified PK/PD expert for the above role based at their site in Gaithersburg, Maryland.

JOB ROLE: The Director/Associate Director will provide PK/PD expertise to pre-clinical and clinical project teams. He/she will collaborate with team members from different disciplines within the company in evaluating and developing clinical drug candidates and apply PK/PD modeling for selection of dose and dosing schedule for pre-clinical and clinical studies.

PRINCIPAL RESPONSIBILITIES include:

QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:

SKILLS & PERSONAL ATTRIBUTES:

BENEFITS OF THE ROLE: This Company's working environment is characterized by an open exchange of ideas and information, individual ideas are highly valued and there are ample opportunities for personal and professional growth. The company is driven by a passion for excellence, using cutting edge technology to achieve their success. They are an equal opportunities employer, offering exceptionally good career development opportunities alongside competitive flexible salaries. For applications or further information please email your CV to: shula@fforde-management.com or telephone our specialist consultant, Shula George, on +1 212 520 8303 who will be pleased to advise you on your personal career needs. Alternatively you may write to us at 2nd Floor, 825 Third Avenue, New York, NY 10022 or Fax: 212-520-8501 Fforde is a uniquely specialised recruitment agency for the pharmaceutical, clinical research and biotechnology sectors. We pride ourselves on a glowing reputation within the industry and a high-quality personalised service dedicated to intelligent delivery. Explore our website and see all our job opportunities. www.fforde-management.com KEY WORDS: Director, Associate Director, PK/PD, Pharmacokinetics, Pharmacodynamics, Pre-clinical Studies, Clinical Studies, Clinical Drug Candidates, PK/PD Modeling, PK/PD Analysis, Simulations, PhD, Biopharmaceutics, NONMEM, Drug Development, WinNonlin, Biotechnology Shula George Recruitment Manager Fforde Management 825 Third Avenue 2nd Floor New York, NY 10022 Telephone: 212 520-8303 Fax: 212 520-8501

Contact email address: contcsc@optonline.net - 9th Nov 2007 [1326]

Bio-analytical Scientist: Preclinical Drug Development

Duties and Responsibilities:

Requirements/Qualifications:

Contact email address: sbell@encoreexecutives.com - 9th Nov 2007 [1324]

Job Summary:

Responsible, with senior staff, for planning and coordinating non-clinical studies undertaken at contract research organizations (CROs) and/or academic institutions to support approval and commercialization of ourproducts. Involves a high level of independent liaison, decision making, and deputization for Manager, Non-Clinical Development.

Job Responsibilities: 1. Work directly with the Non-Clinical Development Manager to plan pharmacology, toxicology, ADME, and bioanalysis studies conducted at external organizations (CROs, academia, other collaborating laboratories). 2. Contribute to study design, external laboratory selection, and study placement (contract development and study initiation). 3. Act as the primary liaison with CROs to coordinate all activities related to contract GLP and non-GLP non-clinical studies, including, but not limited to: 1) constructing and updating the study plan for each study; 2) developing study protocols; 2) monitoring of study progress; 3) coordinating study-related document review and management. 4. Make decisions on study execution, and solve problems in compliance with regulatory requirements, GLP and animal welfare regulations. 5. Review and critique study reports for accuracy, interpretation, adherence to protocol, format and quality, and ensure issuance to agreed timelines. 6. Analyze and interpret study data, prepare study updates, and present the updates at group meetings, project meetings, or for management review. 7. Contribute to the preparation and review of regulatory documents and updates, and responses to agency questions. 8. Liaise with Non-Clinical Discovery laboratory staff, and contribute to planning, integration and review of studies as required. 9. Serve as a Non-Clinical Division representative on multi-disciplinary project team(s); contribute specific expertise and general understanding of drug development to support achievement of project milestones. 10. Acquire the necessary scientific, regulatory and business understanding of relevant projects in order to integrate non-clinical aspects. 11. Coach and train new and more junior staff within the Non-Clinical Division; advise staff in other disciplines as needed.

Job Requirements: * MSc (minimum) or PhD in Pharmacology, Toxicology, Pharmacokinetics & Drug Metabolism, or equivalent. * At least 5 years of relevant experience in a pharmaceutical development environment, with demonstrated ability to work independently. * Well-developed interpersonal, negotiation and diplomacy skills; ability to interact confidently with senior internal staff and manage external customers. * Ability to work under pressure on multiple tasks, and to strict timelines. * General computer literacy and experience with Microsoft Office, and preferably statistics, software. Must be authorized to work and live in Canada. (No immigration services.)

Contact email address: jchapman@haallc.com - 6th Nov 2007 [1319]

Our client is seeking a Director of Pharmacometrics to develop and apply PK and PD modeling methods to improve understanding and drug development.

Requirements: Pharm.D. or Ph.D. 5+ years experience designing and developing PK or PD models. A background in statistics and application of statistics to clinical studies is strongly desired. Experience preparing documents for filings is helpful. Ability to work both independently and within teams, as projects demand. Inclination for intellectual collaboration. Ability to seek out colleagues with complementary skills to establish mutually productive working relationships. Ability to write supporting code to test and implement models. Familiarity with standard PK/PD platforms such as WinNonlin® and NONMEM. A thorough understanding of PK and PD modeling. Excellent verbal and written communication skills are required.

Responsibilities: Work closely and collaboratively with Scientists in other departments. Establish and work within cross-functional teams. Work closely with and manage outside contractors. Participate in the preparation of regulatory documents and other professional reports.

All interested candidates please send your CV to jchapman@haallc.com

Contact email address: joyf@cslrecruitment.com - 31st Oct 2007 [1316]

Clinical Trial Leader III, S.England

Introduction: Permanent career opportunity for an experienced Clinical Pharmacology Study Manager to join a World Class pharmaceutical company in the South of England. International scientific and operational role leading cross functional aspects of respiratory/immunology studies in Phase I/II. Our client is a well renowned world leader in the research and development of new medicines and an employer of choice for many who seek to create an international career path within what is an environment of scientific and commercial excellence. A permanent career opportunity has arisen in the Translational Medicine Scientific Operations department with an opportunity to work on challenging new areas (such as monoclonal antibody studies).

In this role you will provide operational expertise as a Clinical Trial Leader for high complexity exploratory clinical development studies in the Respiratory and Immunology areas, which involves liaising with colleagues from different line functions to plan, co-ordinate and deliver all elements of early phase clinical studies (including first-in-man, proof of concept and mechanistic/profiling studies) from protocol synopsis generation to final reporting.

Summary of Duties:

Qualifications Required:

For more information view this role at www.cslrecruitment.com reference 4006 or email your CV and request to Joy Finney, joyf@cslrecruitment.com. Telephone +44 (0) 01932 228 928. External website http://www.cslrecruitment.com

External website http://www.cslrecruitment.com

Contact email address: gemick@usachoice.net - 30th Oct 2007 [1315]

Job Description: Research Scientist

This position is located in Indiana with a large pharmaceutical company.

KEY OBJECTIVES/DELIVERABLES:

MINIMUM REQUIREMENTS:

ADDITIONAL SKILLS/PREFERENCES:

Contact email address: jchapman@haallc.com - 30th Oct 2007 [1314]

Senior Level Position

Responsibilities: Plan, organize, conduct, interpret and report pharmacokinetic, toxicokinetic and PK/PD studies through internal or external (contracted) resources. Travel to contract laboratories as needed. Participate in drug development project teams and subteams, conveying expertise and advice on PK. Develop procedures and policies for the planning, conduct and reporting of DMPK studies. Prepare and review pharmacokineticportions of regulatory submissions and responses to regulatory agencies. Provide advice and interpretative input to PK-related non-clinical research studies. Prepare and adhere to DMPK portions of project and department budgets.

Requirements: Ph.D. in Pharmacokinetics or a related field. 5+ years with PK/TK/ADME non-clinical drug development experience (clinical PK experience is a plus, as is peptide or protein experience). Experience with the preparation and review of PK/ADME sections of pharmaceutical regulatory submissions. Participation in drug development project teams or subteams. Knowledge of FDA and ICH guidances and regulations applicable to PK/TK/ADME, including expertise in operating according to GLPs or GCPs. Ability to interpret pharmacokinetic data, using industry-standard software such as WinNonlin, and PK-related LIMS such as Watson. All interested please contact me at jchapman@haallc.com by sending your updated CV and I will contact you to discuss the details of your career development interests.

Contact email address: sbell@encoreexecutives.com - 26th Oct 2007 [1311]

Senior Research Associate

Discovery PK/PD Sciences

Description: This position will be primarily responsible for providing bioanalytical support for PK and pharmacology studies, in addition to participating in our continuous effort to increase bioanalytical efficiency. Key functions will include independently planning and conducting bioanalytical studies to determine the concentrations of small molecules and metabolites in various biological matrices (plasma, brain, lung, liver, kidney, etc.), independently developing LC/MS/MS methods and troubleshooting/maintaining LC/MS/MS instrumentation.

The successful candidate will have a BS/MS degree in Analytical Chemistry or a related field, along with 2+ years of direct bioanalytical experience in a pharmaceutical environment. Hands-on experience with liquid handling systems would be a plus, as is a background in writing bioanalytical reports and presenting in department/project team meetings. Must be self-motivated, detail-oriented, flexible, and a team player.

This position is located in San Diego, CA for an exciting company with strong growth. ie. They have $1/2 Billion of cash on hand so the can hire a lot of people. Send me your resume for more details.

External website http://www.encoreexecutives.com

Contact email address: bart.dichiara@penwest.com - 24th Oct 2007 [1307]

Position description

Position Title: Director / Sr. Director, Clinical Pharmacokinetics Department: Clinical Pharmacokinetics & Drug Disposition Reports to: SVP, Pharmaceutical Development Classification: Exempt Location: Patterson, NY Date: October 2007

Company: Penwest Pharmaceuticals Co.: a small, growing, publicly-traded (NASDAQ) specialty pharmaceutical company focused primarily on CNS diseases.

Position Summary: The Director/Sr. Director will assume the responsibility and accountability of the Clinical Pharmacokinetics and Drug Disposition Department. Major responsibilities are: Lead a staff of 4-6 scientists; Participate in defining department goals and maintaining the budget; Manage/Implement all preclinical, safety, and clinical PK of small chemical entities in various phases of development. More specifically, the Director/Sr. Director will develop and

Qualifications:

Contact: Bart Di Chiara, HR Consultant Penwest Pharmaceuticals Co. 39 Old Ridgebury Road, Suite 11 Danbury, CT 06810 Phone: 203-796-3737 Email: humanresources@penwest.com

External website http://penwest.com.

Contact email address: mike@biopharmassociates.com - 23rd Oct 2007 [1303]

Senior Scientist DMPK/Bioanalytics

My client, a Cambridge based biotech company is seeking a Senior Scientist to be responsible for performing and overseeing all bioanalytical efforts for the quantitative analysis of drugs and metabolites in biological matrices in support of the company's drug discovery and development efforts. Ph.D.with 5+ years of experience in industry.Must have good understanding of bioanalytics as well as analyze and report PK data. Mass spectrometry and management skills strongly preferred

Contact email address: hr@nwrpros.com - 18th Oct 2007 [1299]

PK Scientist

Major Duties & Responsibilities:

Requirements:

To apply for this position send your resume via email to: nwrpros@vurvexpress.com with PK Scientist (442844) in the Subject line. To view all of our opportunities - please go to our Career Center: http://nwrpros.com/CareerCenter.html.

Contact email address: candidates@biointegrationsearch.com - 18th Oct 2007 [1298]

Our client, a prestigious biotech company developing anti-cancer therapeutics is looking for an experienced Toxicologist for this great opportunity in the Boston area: TOXICOLOGIST:

Design pre-clinical strategies and studies for Phase I clinical trials for our oncology agents Oversee analysis and prepare reports to document pre-clinical activities Identify and manage outsourcing partners and studies Must have experience in the preparation of regulatory submissions, (IND, BLA, NDA, and MAA experience is helpful.) Candidate must have a PhD in Toxicology, Pharmacology, Biochemistry, or (MD or DVM.) At least 3-5 years of post-doc experience is required. Excellent communication skills and organizational skills are essential. Ability to work in a multi-disciplinary setting, and have strong interpersonal skills. Excellent salary and benefits package provided. Relocation possible. Please forward CV to: Candidates@biointegrationsearch.com

External website http://www.biointegrationsearch.com

Contact email address: kristy@jones-ingham.com - 17th Oct 2007 [1297]

My client has just opened an office in Montreal and is looking to hire Associate Scientists and Senior Associate Scientists

Job Objectives: As integral members of the Reporting and Analysis Services group, the Associates will be mainly responsible for the analysis of PK/PD data from Preclinical and Clinical studies and for writing clinical study reports for submission to regulatory agencies.

Essential Job Functions: The Associates are responsible for all aspects of the projects, including PK/PD and statistical analyses according to state-of-the-art methods and Regulatory Requirements Interpretation of results Clinical study report writing Client interactions

Knowledge/Skills/Abilities: A general knowledge on clinical drug development and a demonstrated knowledge of pharmacokinetics and pharmacology is required Substantial background and expertise in PK analysis, report writing and regulatory requirements is an asset. Expertise in protocol writing, IVIVC, and compartmental analysis (i.e., Population PK/PD analysis, modeling and simulations) is desirable. Excellent verbal and written communication skills in English Proficiency in performing PK and statistical analyses using software such as WinNonlin, SAS, etc.

Minimum Requirements: PhD or MS in Pharmaceutical Sciences or related discipline, with an adequate number of years of industry experience. Candidates with more experience will be considered for the Senior Associate position. Travel Required: < 10%

External website http://www.jones-ingham.com

Contact email address: kristy@jones-ingham.com - 17th Oct 2007 [1296]

Senior Scientist- PK/PD Can be located anywhere in US or Europe. My client has a complex suite of software products serving the pharma and biotech industry, specifically focusing in the area of Pharmacokinetics and Pharmacodynamics. My client will consider a more junior candidate but must be located in RTP NC or Mountain View CA As an integral member of my client's Scientific Consulting Services group, the Senior Scientist interacts with national and international pharmaceutical and biotech company project teams in developing optimal clinical trial designs using pharmacodynamic modeling and simulation. Essential Job Functions: This position is responsible for all aspects of the projects, including defining key trial design issues analysis, PK/PD modeling simulation interpretation presentation of results The Scientific Consultant also interacts with the software engineering group and sales/marketing team in shaping the product features and functionality of future software release and new products development. Knowledge/Skills/Abilities: Strong background and experience in PK/PD modeling with NONLIN, NONMEM, SAS, S-plus a prerequisite. Strong communication skills are highly desirable Minimum Requirements: PhD or MD Minimum 10 years industry experience Travel Required: 10%

External website http://www.jones-ingham.com

Contact email address: erik@biopharmajobs.com - 5th Oct 2007 [1295]

Principal Scientist, Clinical PK One of the premiere biotech companies based in California currently has an opening for a Sr. Clinical Investigator. This position will be responsible for clinical PK/PD modeling in various stages of clinical development. Primary responsibilities are as follows: The Sr. Clinical Investigator will develop and apply PK and PD modeling methods to improve the understanding and development of current drugs and others in development. Initial projects will focus on diabetes and obesity with particular emphasis on dose tolerance, dose proportionality, bioavailability, drug-drug interactions, and special populations. The successful candidate will work closely and collaboratively with scientists in other departments within the company, and is expected to identify appropriate internal resources and establish and work within cross-functional teams. The Sr. Clinical investigator will also work closely with and manage outside contractors. This scientist is expected to participate in the preparation of regulatory documents and other professional reports.

Requirements: An advanced degree (Pharm.D. or Ph.D. preferred, but appropriate experience most important), and at least three years of experience designing and developing PK or PD type models. The candidate should be able to work independently, and within teams as projects demand. The candidate should be familiar and proficient with standard PK/PD platforms such as WinNonlin and NONMEM. A background in statistics and creative application of statistics to clinical studies is strongly desired. Familiarity with regulatory guidelines, and experience preparing documents for filings is helpful. In addition to a thorough understanding of PK and PD modeling, key to success in this role is an inclination for intellectual collaboration, and the ability to seek out colleagues with complementary skills to establish mutually productive working relationships. Candidate is expected to write supporting code to test and implement models. Contact Information: Please email your CV for immediate, confidential review. This is a targeted search for one of the premiere biotech companies based in California, and as such, all candidates will be held in strict confidence. Erik Wm. Lakes, MSc Executive Recruiter The Agency An Employment Consortium 13107 Ventura Blvd., Suite 205 Studio City, CA 91604 Toll Free 1.800.241.2070 Direct 818.906.7000 x 107 erik@biopharmajobs.com

External website http://www.biopharmajobs.com

Contact email address: nuria@discovery-europe.biz - 5th Oct 2007 [1294]

PROJECT CLINICAL PHARMACOLOGIST Location: UK, Switzerland or US Job Purpose: The Project Clinical Pharmacologist has the overall responsibility and accountability of the clinical pharmacology components of drug development and represents clinical pharmacology on the project team. He/she applies high medical, scientific, and ethical standards to define the clinical pharmacology characteristics (safety, pharmacokinetics, and pharmacodynamic) of investigational drugs in a cost and time-efficient manner.

Education/Qualifications: Minimum: * PharmD, PhD, or MD in an area relevant to clinical pharmacology, with relevant clinical and pharmaceutical industry experience in the planning and conduct of clinical trials (preferably early human studies in a pharmaceutical industry setting) * Appropriate computer software experience (including WINNONLIN or other similar PK analysis tool, MS Word, Excel, PowerPoint, etc) * Able to interact authoritatively with regulatory authorities on Clinical Pharmacology issues
Desired: * Experience with advanced data analysis skills (e.g., advanced modeling, population kinetics) * In-depth knowledge of the drug development process, participation in the preparation of a successful NDA * Recognized expertise within the clinical pharmacology community through publication of significant findings contributing to a therapeutic area or the drug development process * Successful track record interfacing with government agencies e.g., FDA, CPMP/EMEA

External website http://www.discovery-europe.biz

Contact email address: nuria@discovery-europe.biz - 5th Oct 2007 [1293]

SENIOR CLINICAL PHAMACOLOGIST Location: Switzerland, UK or US Job Purpose: The role of the Senior Clinical Pharmacologist (Senior CP) is to provide Clinical Pharmacology scientific expertise to the department and to act as due diligence manager for the function. The major task will be to review clinical pharmacology-relevant information of in-licensing opportunities in all development stages, generating an assessment of the opportunity and a plan addressing the characteristics and associated risks of the molecule in question. Additionally, the Senior CP will support the Clinical Pharmacology Management Team in the maintenance and further development of functional excellence. He/she will provide specialist science support for new and emerging areas of Clinical Pharmacology (eg pediatrics, ethnicity, biologics, biopharmaceutics) across all disease areas and lead cross-functional working groups to develop a broad understanding of the topic and provide best practices for efficient implementation. Thus, the Senior CP interacts frequently with members of the Research, Development, Business and Partnering organizations within the company, as well as with external opinion leaders and investigators. Education/Qualifications: Minimum: • The candidate must be a MD, PhD or PharmD with significant experience in clinical pharmacology and a thorough knowledge of drug development. Desired: • In-depth knowledge of the drug development process, participation in the preparation of a successful NDA. • Recognized expertise within the clinical pharmacology community through publication of significant findings contributing to a specific scientific area or the drug development process • Successful track record interfacing with government agencies e.g., FDA, CHMP/EMEA

External website http://www.discovery-europe.biz

Contact email address: alkharfy@ksu.edu.sa - 22nd Sep 2007 [1289]

Faculty positions are available in Riyadh, Saudi Arabia for the followings: 1. Pharmaceutics, pharmaceutical technology and nanotechnology 2. Medicinal chemistry and drug discovery 3. Pharmacology and drug development CVs should be sent to alkharfy@ksu.edu.sa or khast6@yahoo.com. Dr. Khalid Alkharfy

Contact email address: zjhzpl26@hotmail.com - 21st Sep 2007 [1288]

The University of Southern Nevada College of Pharmacy is establishing an extension program in the Salt Lake City, Utah area. The College is currently seeking applicants for full-time faculty positions at the Utah campus in the areas of pharmaceutics and pharmacokinetics. Responsibilities include teaching in blocks and electives related to your discipline, participating in research and scholarly endeavors, and providing service to the College and the community. Minimum requirements include a Ph.D. degree in Pharmaceutics, Pharmacokineitcs or any closely related discipline. The successful candidates should have excellent written and oral communication skills and an interest in teaching, especially creative and non- traditional methods of teaching. Documented evidence of research and other forms of intellectual initiatives are required. Recent Ph.D. graduates are welcome to apply. Salary and rank will be commensurate with qualifications and experience. Candidates should submit a letter of interest, curriculum vitae, statement of educational philosophy, and contact information for three professional references to: Tyler Rose, Ph.D., e-mail: trose@usn.edu. The University of Southern Nevada is an Equal Opportunity Employer.

Contact email address: mark.mcphee@princetonone.com - 14th Sep 2007 [1282]

Scientist I-Pharmacokinetics; position no. MMM 1312

My client is an established, mid-cap pharmaceutical firm with a long history of developing a wide variety of therapeutics to treat various human diseases. Their Pharmacokinetics group seeks a Scientist who has a good understanding of drug kinetics and biopharmaceutics. This position is located in the Mid-Atlantic region.

Please send a cover letter and resume (in MS Word format, please) to: Mark.McPhee@PrincetonOne.com

Description:

The incumbent Phamacokineticist will support the PK/DM Department. Must be knowledgeable of FDA policies and procedures, related to BE and PK Phase I testing. Specific job duties may include:

Study Design and Execution

-Design, monitor and accurately report data from BE and PK studies that support ANDA and NDA submissions, respectively, for approval in order to get products into the market. -Assembles review of BE Reference product for PK Consult. For PK studies, assembles review of study-specific information for drug product. -Creates Protocols for Clinical Studies and assembles review of literature, reporting and summarization with respect to PK characterization. -Train CRO staff (or Clin/PK Ops) on Protocols, answer questions on study design, and monitors studies to ensure studies are conducted appropriately from a PK perspective. -Ensures study documentation is written accurately. Interact with Product Development regarding planning.

Project Overisght and Goals Updates

-Provide periodic briefings to Formulation Group and interact with Clinical/PK Operations, regarding monitoring study at clinical sites. -Interact with Bioanalytical Lab regarding assay development, moieties to be measured, suitable assay range, sample handling procedures and study execution. -Interact with Program Manager, Quality Specialist and Product Development regarding planning. -Based on interpretation of results from BE & PK studies, provide feedback to other departments. Assume responsibility for preparation and assembly of final BE & PK reports.

Data Review and Document Preparation

-Review data for: subject exclusion, time deviations, Kel picks and PK characteristics. Review results and data from a study. -Upon concurrence with management, write explanation and discussion section on how to interpret the data. This requires integrating theories and rationale to support conclusion(s) and their meaning(s). -When appropriate, apply scientific methodology and to propose solutions to formulation/bioequivalence hurdles. -Assist in preparation and review of electronic submissions. Assist in review and signoff of final BE & PK reports. Assist in answering FDA questions or addressing Citizen’s Petitions with respect to Pharmacokinetics.

Requirements:

-Ph.D. with 0-3 years of experience or M.S. degree with 3+ years of experience working in Pharmacokinetics or clinical trials required (Kinetics or Industrial Pharmacy background, preferred). -Must possess strong analytical and complex problem solving skills. -Must possess strong writing, communication, and presentation skills. -Must be able to manage multiple projects, have strong computer skills and a working knowledge of Microsoft Office Suite, PK Statistical Program, Sigma Plot, and Lotus Notes. -Must possess in-depth knowledge of CFR, SOPs and FDA regulations and industry guidance. -Additional experience with nasal or topical dosage forms considered a plus.

Keywords: small molecule, pharmaceutical, pharmacokinetics, PK, oral solid, nasal, topical, NDA, ANDA, FDA, ICH, clinical Phase I, bioequivalence, biopharmaceutics, protocols, CRO oversight, scientist

External website http://www.mrinetwork.com/pcrbin/recruiters.exe?action=details&recruiter_id=174365778035012

Contact email address: pbowser@brunelmultec.ca - 13th Sep 2007 [1280]

My client, a biotechnology company in Vancouver, BC is searching for qualified candidates for the following position:

The Senior Scientist, Pharmacology & Toxicology will provide in-depth scientific and technical guidance towards the understanding of the pharmacology, pharmacodynamics, kinetics and toxicology of locally delivered drugs for a wide variety of drug-device applications. The successful candidate will have 5+ years of industry experience working in drug or device development settings, and will be able to facilitate the rapid development of a variety of products within a project team environment. This position will pay ~$100-120K, commensurate with experience and qualifications, and relocation assistance will be provided.

In this role, you will work with a product development team to design and conduct scientific studies in the areas of local drug delivery, cell uptake, in vitro and in vivo kinetics, pharmacodynamics and toxicology. You will be responsible for reviewing and summarizing technical information to support regulatory filings of drugs and devices within a broad array of mechanistic classes.

Applicants must hold a PhD in Pharmacology, Toxicology, Pharmacokinetics or a closely related discipline and have a strong understanding of drug kinetics, pharmacodynamics and toxicology. Expertise in disease processes related to inflammation, infection, or wound healing would be a strong asset, as would experience in histopathology. This position calls for a timeline-sensitive high performer with excellent interpersonal and communications skills.

Vancouver is consistently ranked as one of the three most livable cities in the world.

External website http://www.multec.ca/db/jobdetails.php?id=1644&f1=&f2=

Contact email address: maguire.sherry@gene.com - 12th Sep 2007 [1279]

Genentech has an opportunity available in our South San Francisco, CA facility for a:

Oncology Pharmacodynamic Biomarker Sr. Scientist The department of Pharmacodynamic (PD) Biomarkers is seeking a highly motivated senior scientist to join our Oncology PD Biomarker group. Responsibilities will include developing PD biomarker strategies for oncology targeted therapeutics (both large and small molecules). The ideal candidate will have extensive experience preclinical pharmacology; specifically the ability to translate preclinical PK/PD information in to an impactful PD biomarker strategy for clinical development. Experience using PD data for decision making in clinical development is essential. The successful candidate will direct PD biomarker assay development and implementation strategies for both clinical and non-clinical trials. Strong leadership and managerial skills to allow coordination of multiple projects are required for this position. The candidate will also be responsible for maintaining and developing the relationship of the PD Biomarker group with key stakeholders in research, PK/PD sciences, diagnostics, biostatistics, and oncology early clinical development.

Requirements: Candidates must have a PhD or MD/PhD with seven or more years of industrial experience. Preferred candidates will have experience in preclinical pharmacology, development of PD biomarker assays, and their implementation in clinical trials. The candidate must have excellent communication skills and the ability to work on interdepartmental project teams.

Interested candidates, please email resume to Maguire.Sherry@gene.com Genentech is dedicated to fostering an environment that is inclusive and encourages diversity of thought, style, skills and perspective. Genentech is an Equal Opportunity Employer.

External website http://www.gene.com

Contact email address: maguire.sherry@gene.com - 12th Sep 2007 [1278]

For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to develop novel medicines for serious and life-threatening diseases. Today, Genentech is among the world's leading biotech companies, with multiple therapies on the market for cancer and other unmet medical needs. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset. We have an opportunity available in our South San Francisco, CA facility for a:

Associate Director/Director Oncology Pharmacodynamic Biomarkers The Department of Early Development Pharmacokinetics, Pharmacodynamics and Bioanalytical Sciences is a Translational Pharmacology group dedicated to helping to translate novel research discoveries into effective therapeutics for unmet medical needs. An important part of our success is the use of relevant and novel PD-biomarkers to help drive our decision making on which drugs to bring forwards and how to dose them appropriately. We are currently looking for a highly skilled and passionate leader of our Oncology Pharmacodynamic Biomarkers group. The successful candidate will lead a large group of scientists and research associates to successfully integrate PD-biomarkers strategies and assays into our preclinical and clinical development programs. He/She will provide scientific leadership for the company's efforts to develop PD-biomarker strategies and novel assays to determine drug MOA, activity and relevant biological effects in patients. This candidate will be expected to form close collaborations with our Research Discovery, Diagnostics, Clinical Oncology, Safety and PKPD groups. Primary responsibilities are as follows: Provide scientific leadership for the company's Pharmacodynamic-Biomarker strategies for all oncology projects. Advance our understanding of the pharmacology of our drugs and cancer. Integrate PD-markers into our drug development programs when appropriate. Provide first class strategic and scientific advice regarding Oncology-Biomarkers to Peer Review Committees and Senior Leadership. Drive scientific and technical innovation. Work with Departmental and Senior Leadership to prioritize Biomarker programs to ensure optimal use of resources.

Requirements: PhD or M.D./PH.D. degree in relevant scientific field (e.g. Pharmacology, Pathology, Molecular biology ,Cancer biology, Molecular Oncology). A strong knowledge of PD-biomarkers and their use in defining PK/PD and dose-response relationships is attractive, but not mandatory. A minimum of eight(8) years post-doctoral basic or clinical research experience. Demonstrated record of cutting edge research as evidenced by first- or senior-authored publications in top-tiered journals. Reputation as a leader in field, as demonstrated by invited lectureships, invitations to write review articles and referee grants and manuscripts. Demonstrated record of designing and implementing PD-biomarker strategies. Experience in developing Biomarker assays, preferably in the context of determining clinical effectiveness of compounds, is desired. Relevant industry experience highly preferred. Excellent cross-functional team leadership and participation skills. Ability to build, lead and manage a large group of highly motivated scientists is required. Ability to lead, influence and motivate others, both within direct supervisory and matrixed environments. Ability to demonstrate effectiveness and growth in a fast-paced and dynamic environment.

Interested candidates, please email resume to Maguire.Sherry@gene.com Genentech is dedicated to fostering an environment that is inclusive and encourages diversity of thought, style, skills and perspective. Genentech is an Equal Opportunity Employer.

Contact email address: bob.hale@genzyme.com - 12th Sep 2007 [1277]

Principal Research Associate You will be part of a team providing drug metabolism and pharmacokinetic information for Genzyme’s small molecule drug discovery and development programs. The candidate will be responsible for the development and qualification of methods to quantitate new chemical entities and their metabolites to support in vitro and in vivo drug metabolism and pharmacokinetic studies. Techniques used will include LC-MS/MS and automated approaches for higher throughput. The individual will be responsible for the quality and interpretation of their data, and for ensuring timely documentation and communication of results. The ability to effectively contribute both individually and in a team setting is essential. The successful candidate will have strong communication, interpersonal skills, and ability to work in a challenging and fast-growing environment.

Requirements: A BS/MS in pharmaceutical science, biochemistry or related field with 8 years of relevant industrial experience within a DMPK function is required. Expertise in the application of LC-MS/MS for the analysis of biological matrices is required.

External website http://www.Genzyme.com/careers

Contact email address: alkharfy@ksu.edu.sa - 12th Sep 2007 [1276]

A newly established diabetes research center located in Riyadh, Saudi Arabia is having positions for highly qualified scientists (Ph.D. or Msc. holders) with extensive experience to fulfill the following positions: 1. Pharmaceutical scientists in drug delivery and pharmaceutical formulations/nanotechnology 2. Diabetes research associates in drug therapy 3. Diabetes gene therapy scientists 4. Antidiabetics discovery and development scientists Excellent inter-personal, communication, and presentation skills are required. Good organizational and problem-solving skills are also required. Must work effectively in a team environment. Must be proficient with computers and software such as Microsoft Word, Excel, PowerPoint and others as per required. CVs should be sent to alkharfy@ksu.edu.sa or khast6@yahoo.com Dr. Khalid Alkharfy King Saud University Riyadh, Saudi Arabia

Contact email address: mike@pharmaes.com - 10th Sep 2007 [1269]

Our client, a world leading pharmaceutical company with several marketed blockbuster drugs and a strong R & D pipeline seeks a seasoned Discovery/Preclinical Drug Metabolism & Pharmacokinetics leader.

DIRECTOR, CNS DMPK

Responsibilities: Reporting into the Senior Director, CNS DMPK, you will exercise strategic leadership and supervision of a group of scientists (10-15 FTEs) providing ADME support for the CNS portfolio. This group of scientists is responsible for identifying and prosecuting DMPK strategies spanning the Discovery & Development continuum from therapeutic idea through loss of exclusivity, for CNS programs. This individual will develop strong partnerships/relationships across groups within a matrix environment, optimizing synergy between groups including bioanalytical resources. Similarly, the candidate will carry a shared responsibility for sustaining a productive environment for DMPK colleagues at the site and maintain strong partnerships with other Research, Development, and FSL lines. Exercise visionary leadership with regard to the future direction of the CNS DMPK organization, in addition to tactically and strategically partnering effectively across multiple R & D lines to ensure alignment, along with championing opportunities for continual improvement in productivity and quality in DMPK.

Qualifications: PhD or equivalent in Pharm Sciences, Biology, or Chemistry. Minimum of 10 yrs R & D experience in ADME science areas with specific experience in applying Pharmacokinetic and Drug Metabolism science and portfolio management from therapeutic idea through loss of exclusivity. Strong track record of managerial/supervisory and leadership excellence: proven success in talent identification, and development, experience working within a matrix management environment, as well as innovative management experience, a proven ability to develop strong partnerships across divergent groups, and strategic agility and business acumen. Intimate knowledge of DMPK science as applied to the progression of compounds, along with integrative knowledge, applied to effectively implementing strategies across the drug discovery and development continuum; Practical working knowledge of study conduct and technical challenges associated with DMPK research. High focus on performance, pushing self and others to excel; conveying a sense of urgency, and holding others accountable to the mission of the department, and wider organization. High level of commitment to developing talent, along with transparent and communicative leadership with reports (direct and indirect). Superior communication and overall interpersonal skills.

QUALIFIED AND MOTIVATED LEADERS MAY SUBMIT THEIR CV IN CONFIDENCE TO: Michael Aloisi Consultant, Pre-Clinical Sciences Global Search Solutions, LLC Phone (914) 630-1109 Fax (914) 381-0627 mike@pharmaes.com

Contact email address: maria.fitzgerald@genzyme.com - 7th Sep 2007 [1267]

Position Description

The DMPK and Pharmaceutics department at Genzyme Drug and Biomaterial R&D is seeking a Staff Scientist. In this role, the candidate will be responsible for the development and implementation of a cell-based permeability assay. The candidate will be dedicated to operation of this protocol including cell culturing, permeability assay, analysis, data processing and interpretation. The ability to effectively contribute both individually and in a team setting is essential. The successful candidate will have strong communication, interpersonal skills, and ability to work in a challenging and fast-growing environment.

Requirements: A Ph.D. in pharmaceutical science, biochemistry or related field with at least 1 year of relevant industrial experience within a DMPK function is required. Alternatively a BS/MS level with 8+ years of experience would be considered. Experience with cell-based permeability models (CACO-2/MDCK) and analysis by LC-MS/MS is essential.

External website http://www.genzyme.com

Contact email address: myoon@impaxlabs.com - 6th Sep 2007 [1266]

Job Title: Pharmacokineticist - Brand

Department: Brand Product Development Reports to: VP of Brand Product Development Date Approved: 9-6-07

Job Summary: Coordinate the interpretation of BE study results in terms of the known literature PK of the drug being developed. Act as the focal point for development of in vivo / in vitro correlations using clinical data and analytical dissolution results. Perform PK modeling to optimize the development of controlled release formulations.

Responsibilities:

Qualifications:

External website http://www.impaxlabs.com

Contact email address: myoon@impaxlabs.com - 6th Sep 2007 [1222]

Job Title: Director - Clinical Pharmacology,PK/PD

Department: Product Development – Brand

Job Summary: This position will be responsible for providing scientific oversight and direction to the Clinical Pharmacology, Pharmacokinetics and Pharmacodynamics Area. Responsible for ensuring the integrity of regulatory documents provided by the department.

Responsibilities:

Qualifications:

External website http://www.impaxlabs.com/

Contact email address: RSA@sedona.net - 30th Aug 2007 [1258]

Sr BioAnalytical Chemist
LC/MS/MS - GLP

Our client is looking for an emerging or seasoned bioanalytical manager to run their new GLP lab. This is a senior level position within the company.

This person will be doing methods development and troubleshooting using LC/MS/MS for clinical sample analysis of biological matrices. S/He will immediately be supervising has six chemists and will manage the rapid growth of the lab.

S/He will help set up Quality systems and in the next few months will need to double and then triple the number of chemists plus purchase new equipment.

GLP experience mandatory.

If you have an interest in this or other opportunities, please send your resume as a MS Word compatible file attached to email to the attention of Basirah at RS&A. All correspondence is held in strict confidence.

(Ms) Basirah Nur Al'Basit RS&A - Scientific Recruiters PO Box 2337 Sedona, AZ 86339-2337 USA TEL: (928) 203-0074 EM: RSA@sedona.net

Contact email address: larry@glinesassociates.com - 27th Aug 2007 [1255]

We have been retained to conduct a search to find a Discovery Toxicologist. Our client is a biopharmaceutical company applying its’ discoveries in human genetics to the development of drugs and diagnostics for common diseases. A global leader in gene discovery, the Company’s population approach and resources have enabled them to isolate key genes contributing to major public health challenges from cardiovascular disease to cancer. In addition to leveraging their capabilities for proprietary product development programs, they provide services in genotyping, structural biology, drug discovery and development and clinical development to pharmaceutical and biotechnology companies. Their services range from early-stage discovery and optimization to identification of viable synthetic routes required to manufacture cGMP material in quantities for pre-clinical and clinical studies. The Company’s Chemistry & Biostructures division conducts drug discovery and development for pharmaceutical and biotechnology companies using an integrated platform of structural biology and chemistry technologies. Their collaborations are designed to help clients to focus their resources on developing small molecule therapeutics that have the greatest promise of efficacy, selectivity, and safety in the clinic. The core requirements are substantive background in small molecule therapeutics with in-depth knowledge of in vitro and in vivo studies related to toxicology, safety pharmacology, PK, PD. Experience with approaches in Cardiology or Inflammation is a big plus. The Compensation package will include a competitive base salary, bonus, options and an attractive benefits package. Please consider this in evaluating this opportunity. Please let me know if you know of anyone who meets the profile of the position which is based in suburban Chicago. I appreciate your interest, courtesy and time. Larry Glines 312-580-0646 www.glinesassociates.com Delivering the Best Talent in Healthcare & Life Sciences

External website http://www.glinesassociates.com

Contact email address: awelch@gene.com - 22nd Aug 2007 [1252]

Genentech Inc.- Sr. Scientist DMPK

The Drug Metabolism and Pharmacokinetics (DMPK) department at Genentech is seeking a highly motivated individual with proven abilities who will be involved in the design, execution, supervision, and interpretation of nonclinical pharmacokinetic studies. These studies will enable the selection of small molecule drug development candidates and provide assessment of their pharmacokinetic/ADME characteristics to support drug development. The individual will be involved in the following activities as part of their role: Representation of DMPK at interdisciplinary project teams Pharmacokinetic & pharmacodynamic data analysis and modeling Report writing & IND and NDA filings Mentoring & supervision of staff Set-up and validation of in vivo/in vitro ADME/PK models

Requirements: A PhD degree in pharmacokinetics, drug metabolism or other relevant fields. 5+ years of relevant pharmaceutical industry experience. Experience with regulatory filings is required. Good organization skills, communication skills and flexibility are essential. Desirable: Familiarity with pharmacokinetic software such as WinNonLin, ADAPT, SAAMII, NONMEM and drug metabolism concepts. Experience in supervision of staff.

REQUISITION NUMBER: 07-1000020053 SR Sci DMPK

External website http://www.gene.com/

Contact email address: jchapman@haallc.com - 17th Aug 2007 [1250]

We are currently searching for Director/Senior Director of Clinical PK / Pharacology group. This position is responsible for the design, execution, analysis and interpretation of pharmacokinetic studies conducted during drug development Phase I-IV. The position locations are in CA and MA.

The responsibilities include but are not limited to: • Responsible for all clinical PK/PD studies within the company • Interact with nonclinical pharmacology, pharmacokinetics, and toxicology scientists to select the projected therapeutic dose and the dose range in the first in human study • Interact with clinical development to evaluate optimal therapeutic dose and to seek population PK and PK/PD relationships in phase II studies • Prepare/review the clinical pharmacokinetic portion of the clinical development plans and clinical protocols • Design clinical drug interaction studies with input from nonclinical drug metabolism and pharmacokinetic evaluations • Perform data analysis (PK, PD, PK/PD, population PK/PD) and modeling, prepare reports, provide general support for drug development activities • Interact with regulatory agencies (e.g. FDA) as required including document filing • Participate on project teams

Requirements Ph.D., Pharm. D. or equivalent in Applied Mathematics, Pharmacokinetics, Statistics or Clinical Pharmacology or other related discipline. A minimum of 5 years of experience as a clinical pharmacokineticist. Hands-on experience in statistical analysis of PK data and in conducting simulations is required. All interested parties send your updated CV to jchapman@haallc.com and we will call you to discuss the details of your career development.

Last update: Fri 8 Feb 2008 10:00:05 am

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