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Director, Clinical Pharmacology
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Full-time
- The Director, Clinical Pharmacology, will be responsible and accountable to lead and execute clinical pharmacology and modeling and simulation (M&S) strategies and activities from early through late-stage clinical development and approval, including post marketing activities, aiming to bring the value of model-informed drug development to our R&D portfolio.
- Develop and lead clinical pharmacology and M&S strategies for development compounds from pre-IND and first-in-human to later phases of clinical development (phase 2 and 3 studies and NDA/MAA submissions) to enable development and regulatory decisions
- Lead the design, execution, analysis, interpretation, and report of clinical pharmacology studies (e.g., food effect, BA/BE, human ADME, drug interactions, renal and hepatic impairment, etc.)
- Develop and maintain collaborative relationship with colleagues within the department, internal stake holders (i.e., DMPK, toxicology, biology, translational medicine, medical, clinical, biometrics, regulatory, clinical operations, CMC, etc.)
- An advanced degree (PhD, MD, or PharmD) in pharmaceutical sciences, pharmacokinetics, pharmacology, or a closely related scientific discipline plus at least 8 years of pharmaceutical industry experience in clinical pharmacology and/or pharmacometrics with a record of increasing responsibility and independence
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