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About the role
Key responsibilities & impact- Lead clinical pharmacology and pharmacometrics strategy and execution for rare disease and oncology clinical programs
- Develop clinical pharmacology and pharmacometric strategies supporting product development plans
- Serve as Clinical Pharmacology lead for clinical development programs and representative for regulatory interactions
- Perform and/or oversee modeling and simulation to solve drug development questions and expedite decision-making
- Provide clinical pharmacology input on Phase 1–3 clinical studies and dedicated Phase 1 clinical pharmacology studies
- Author and review clinical pharmacology sections of Investigator’s Brochures, INDs, NDAs, and other regulatory submissions
- Act as clinical pharmacology expert during health authority interactions
- Collaborate with clinical study, translational, preclinical, and due diligence teams
- Work within Recursion’s Pharmacometrics team across Discovery and Development projects
Requirements
What you’ll need- Ph.D. in Pharmaceutical Sciences, Pharmacokinetics or related discipline, M.D. with Clinical Pharmacology expertise, or Pharm.D. with a Clinical Pharmacology fellowship
- 10+ years of experience in biotech/pharmaceutical drug development
- Demonstrated success leading all clinical pharmacology-related aspects of drug development
- Experience managing PK, PK-PD, and PK-safety analyses, including non-compartmental analysis, population PK modeling, and PK-PD modeling and simulations
- Proficiency with WinNonlin, Monolix, NONMEM, R, or other modeling software
- Experience responding to regulatory agency questions, preparing clinical pharmacology aspects of regulatory submissions, and attending regulatory meetings
- Ability to collaborate with internal and external stakeholders
- Experience in oncology is preferred, but not required
Benefits
Comp & perks- Annual bonus eligibility
- Equity compensation
- Comprehensive benefits package
- Periodic travel
