SC.AS.Senior Director, DMPK

Proclinical is currently seeking a Director / Senior Director, DMPK for a biopharmaceutical company, in San Francisco CA. Successful candidate must contain capability of contributing to both drug discovery and development projects, and working in collaboration with colleagues in Research, Development Sciences, and Clinical Development. This position will report to the CSO and Head of R&D.

Skills and Responsibilities

• Supporting project teams across multiple therapeutic areas.
• Providing recommendations for key in vitro ADME, in vivo pharmacokinetics, biomarker studies, and contributing to the project strategy as an integrated member of project teams.
• Assuming lead role in outlining internal experimental protocols and addressing key ADME properties as part of the drug discovery workflow.
• Engaging Biologists, Chemists, and other scientists, and the DMPK team to working collectively.
• Completing PK/ADME profiling for INDs and other documents for health authorities.
• Writing and/or contributing to DMPK/BA sections of regulatory filings.
• Designing and conducting metabolite identification and other hypothesis to aid in lead optimization, candidate selection, and clinical development of NCEs for novel drug targets.
• Executing workflow designed to inform Metabolites in Safety Testing strategy.

Requirements

• PhD in Drug Metabolism, Pharmacokinetics, Chemistry or related scientific field with 5+ years of biotech/pharmaceutical drug discovery and development experience; or BS/MS with 10+ years of experience.
• Ability to plan, organize, and critically assess and/or perform PK/PD data analyses. First-hand experience of modeling-aided drug development. Hands-on experience with standard PK software including WinNonlin and NONMEM. Experience with other software such as S-Plus/R and GastroPlus is a plus.
• Execute workflow designed to inform a Metabolites in Safety Testing (MIST) strategy.
• Familiarity with localized drug delivery (e.g., GI tract, lung, skin).
• Demonstrated capability to mentor junior scientists and manage in a matrix environment.
• Excellent oral and written communication skills and the ability to influence.
• Passion for data analysis, solving technical problems and applying new technologies to further scientific goals.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Andrew Shen at (+1) 646-367-1089 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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