Executive Director, Clinical Pharmacology/Pharmacometrics

Role: Lead clinical pharmacology and pharmacometrics strategy for rare disease and oncology programs, focusing on accelerating drug development and regulatory interactions. Responsibilities: develop modeling and simulation approaches (PK, PK-PD, PK-safety), design clinical studies from Phase 1-3, author regulatory documents (IB, INDs, NDAs), and serve as the clinical pharmacology expert in regulatory discussions. Collaborate closely with cross-functional teams including clinical, translational, preclinical, and regulatory groups. Requirements: Ph.D. in Pharmaceutical Sciences, Pharmacokinetics, or related field, or MD with Clinical Pharmacology fellowship; 10+ years in biotech/pharma drug development; expertise in modeling software (WinNonlin, NONMEM, R, Monolix); proven regulatory experience, including responding to agency questions and preparing submissions. HighValue: oncology and rare diseases, clinical pharmacology, modeling and simulation, regulatory strategy, cross-functional collaboration. WorkSetup: remote in the US with periodic travel.