Director, Clinical Pharmacology

Job description

Your work will change lives. Including your own. The Impact You’ll Make: You will join an innovative and passionate clinical development team dedicated to improving the lives of patients suffering from devastating diseases. You will lead the innovative clinical pharmacology and pharmacometrics strategy and execution for a portfolio of rare disease and oncology clinical programs. In this role, you will: - Develop the clinical pharmacology and pharmacometric strategies to accelerate and support the overall product development plan. You’ll be the Clinical Pharmacology lead for various programs in clinical development, the representative for regulatory interactions, and propose innovative strategies to get therapies to patients faster. - Design clinical studies. You’ll provide (clinical) pharmacology input on all clinical study designs, from Phase 1-3 and dedicated Phase 1 clinical pharmacology studies. - Author review relevant clinical pharmacology sections for regulatory documents, including Investigator's Brochures (IB), INDs, NDAs, and other regulatory submissions. Act as the clinical pharmacology expert during interactions with health authorities. - Interface with cross-functional...