Director, Clinical Pharmacology

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., Investigator’s 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
• Master’s (or equivalent) + 15+ years relevant experience.
• Typically 3 years supervisory/management experience.

Pay Range:

• $200,000 - $300,000.

Flex Designation:

• Hybrid or On-Site eligible.

Benefits (explicitly stated):

• Annual bonus and annual equity awards; medical/dental/vision; paid time off; educational assistance (incl. student loan repayment); commuting subsidy; matching charitable donations; 401(k).