Director, Clinical Pharmacology

Responsibilities

• Develop clinical pharmacology and pharmacometric strategies to support product development plans
• Act as the Clinical Pharmacology lead for various programs and representative for regulatory interactions
• Design clinical studies from Phase 1-3, including dedicated Phase 1 studies
• Author and review clinical pharmacology sections for regulatory documents like IBs, INDs, and NDAs
• Interface with cross-functional teams including clinical, translational, preclinical, and due diligence teams
• Oversee or perform modeling and simulation to solve drug development problems

Requirements

• Ph.D. in Pharmaceutical Sciences, Pharmacokinetics, or related discipline; or M.D. with Clinical Pharmacology expertise; or Pharm D. with a Clinical Pharmacology fellowship
• 5-9+ years of experience in biotech/pharmaceutical drug development
• Demonstrated success leading clinical pharmacology aspects of drug development
• Experience managing PK, PK-PD, and PK-safety analyses (non-compartmental, population PK, and simulations)
• Proficiency with WinNonlin, Monolix, NONMEM, R, or other modeling software
• Experience responding to regulatory agency questions and preparing regulatory submissions

Preferred Qualifications

• Experience in oncology

About the Company

Recursion is a clinical-stage TechBio company decoding biology to radically improve lives. Using its AI-native Recursion OS, the company integrates biology, chemistry, and clinical development into a unified intelligence system to translate complex science into medicines for oncology, rare disease, neuroscience, and immunology.