Executive Director, Clinical Pharmacology/Pharmacometrics
Core
Lead clinical pharmacology and pharmacometrics strategy and execution for rare disease and oncology clinical programs to accelerate product development and regulatory interactions.
Role type
Senior IC clinical pharmacology/pharmacometrics executive director
Builds
Clinical development plans, regulatory submissions (IB, IND, NDA), and modeling/simulation outputs for dose selection and exposure-response analyses
Domain
Biopharmaceuticals, oncology, rare diseases
Deliverable
production ML models
Required skills
Clinical pharmacology strategy, population PK modeling, PK-PD modeling, regulatory submission authoring, cross-functional stakeholder management, WinNonlin, Monolix, NONMEM, R
Preferred skills
Oncology experience
Technologies
WinNonlin, Monolix, NONMEM, R
Responsibilities
Develop clinical pharmacology and pharmacometric strategies; oversee modeling and simulation to solve drug development questions; design clinical studies (Phase 1-3); author regulatory documents; interface with cross-functional teams (clinical, translational, preclinical, due diligence)
Seniority
Senior, hands-on IC with leadership responsibilities