Director, Clinical Pharmacology
Core
Lead quantitative and clinical pharmacology across non-clinical and clinical development phases to optimize dosing strategies and trial design using Model-Informed Drug Development (MIDD) approaches.
Role type
Director, Clinical Pharmacology
Builds
Drug discovery and development programs for novel medicines across small molecules, large molecules, and novel platforms.
Domain
Biotechnology / Clinical Pharmacology / Pharmacometrics
Deliverable
production ML models | product features
Required skills
Quantitative Clinical Pharmacology, Model-Informed Drug Development (MIDD), Population PK/PD, PBPK, NONMEM, R, Monolix, WinNonlin, GastroPlus, SimCyp, Regulatory document authoring, CRO management, AI-enabled data analytics
Preferred skills
Experience with IND-enabling and Phase 1-3 trials, Translational Safety, Biomarkers, DDI risk assessment, QSP approaches
Technologies
NONMEM, R, Monolix, WinNonlin, GastroPlus, SimCyp
Responsibilities
Build and own clinical pharmacology capability; lead modeling and simulation approaches; manage external collaborations and CRO partnerships; author regulatory documents (IB, IND, NDA/BLA/MAA); interface with cross-functional teams; incorporate AI-enabled approaches into workflows.
Seniority
Director, strategic leadership with hands-on technical execution
