Recursionpharmaceuticals
Executive Director, Clinical Pharmacology/Pharmacometrics
Remote Opportunity - United Kingdom. Posted a month ago
The role
You will lead clinical pharmacology and pharmacometrics strategy and execution for a portfolio of rare disease and oncology clinical programs. You will develop strategies, design clinical studies, and perform or oversee modeling and simulation to support product development.
What you will do
- Develop clinical pharmacology and pharmacometric strategies to support product development plans
- Act as Clinical Pharmacology lead for various programs
- Represent the company in regulatory interactions
- Perform or oversee modeling and simulation to expedite decision making
- Provide pharmacology input on clinical study designs from Phase 1-3
- Author clinical pharmacology sections for regulatory documents like IB, IND, and NDA
- Act as clinical pharmacology expert during health authority interactions
- Interface with cross-functional teams including clinical, translational, preclinical, and due diligence teams
Required qualifications
- 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
- 10+ years of experience in biotech/pharmaceutical drug development
- Demonstrated success leading all clinical pharmacology related aspects of drug development
- Ability to manage 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
- Effective skills in driving collaboration, achieving results, influencing, and resolving conflicts
- Demonstrated experience responding to regulatory agency questions and preparing regulatory submissions
Nice to have
- Experience in oncology
Benefits
- Annual bonus
- Equity compensation
- Comprehensive benefits package
About the company
Recursion is a clinical-stage TechBio company decoding biology to improve lives. It uses the Recursion OS, an AI-native, end-to-end drug discovery and development platform.