General Summary:
- Director, Clinical Pharmacology leads strategic, scientific and operational aspects at a program level; represents department on cross-functional program teams; develops clinical pharmacology plans; supports departmental management via program reviews; supervises asset leads and provides career development; co-leads cross-functional efforts and leads department initiatives.
Key Duties and Responsibilities:
- Guides metabolic, co-dosing, and drug-drug interaction issues with cross-functional colleagues.
- Co-leads/serves on cross-functional committees; contributes to or leads departmental initiatives.
- Creates protocol concepts; guides protocol start-up (site initiations, investigator meetings).
- Oversees and contributes to regulatory and safety documents.
- Contributes to clinical pharmacology summary documents.
- Guides PK analyses; performs PK/PD or exploratory analyses and guides PK/PD modeling/simulations.
- Provides management and career development; assists in recruitment and hiring.
- People management for assigned staff (may include financial and HR responsibilities).
Knowledge and Skills:
- Expert in Clinical Pharmacology; strong leadership, critical thinking, scientific/development judgment.
- Experience planning/executing Clinical Development Plans for new clinical entities.
- Experience conducting/supervising clinical studies (DDI, special populations, bioavailability).
- Experience with non-compartmental PK and PK/PD analyses.
- Exposure across first-in-human, proof-of-concept, and registrational studies.
- Experience with clinical/regulatory documents (e.g., Investigatorโs Brochure) and regulatory correspondence; matrix experience.
Education and Experience:
- Ph.D. or PharmD (or equivalent) in pharmacokinetics/pharmacometrcs/clinical pharmacology/translational development + 10+ years post-doctoral, or
- Masterโs (or equivalent) + 15+ years relevant experience.
- Typically 3 years supervisory/management experience.