Director, Clinical Pharmacology

Full 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 teams. You’ll work closely with clinical study teams, translational teams (DMPK, Translational Modeling and Toxicology), preclinical teams and due diligence teams to ensure clinical pharmacology-related considerations are addressed. - Solve drug development questions/problems by overseeing and/or performing modeling and simulation with various tools to expedite decision making. The Team You’ll Join You will join the Development Sciences team within Recursion comprising clinical pharmacology, pharmacometrics, translational modeling and clinical biomarkers. The Development Sciences group sits within Recursion’s Clinical Development organization. Team members get to sit on both Discovery and Development projects and work in a seamless end-to-end environment at Recursion. The team collaborates closely with clinical development functions (clinical science, clinical operations, regulatory affairs, biostatistics, etc.), as well as discovery functions (DMPK, Biology, Chemistry and Translational Biomarkers). The Experience You’ll Need - Ph.D. in Pharmaceutical Sciences, Pharmacokinetics or related discipline, M.D with a Clinical Pharmacology expertise, or a Pharm D. with a Clinical Pharmacology fellowship, with 5-9+ years of experience in biotech/pharmaceutical drug development. - Demonstrated success leading all clinical pharmacology related aspects of drug development See the full posting when you apply.