Candidate Availability
Required and preferred rules are kept separate and reflect the wording in the original posting.
About the Role
You will lead clinical pharmacology and pharmacometrics strategy for clinical development programs. You will guide modeling and simulation, design clinical studies, prepare regulatory documentation, support health-authority interactions, and coordinate pharmacology considerations with cross-functional stakeholders.
Requirements
- Ph.D. in Pharmaceutical Sciences, Pharmacokinetics, or a related discipline; M.D. with Clinical Pharmacology expertise; or Pharm.D. with a Clinical Pharmacology fellowship
- 10+ years of experience in biotech or pharmaceutical drug development
- Demonstrated success leading clinical pharmacology 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 components of regulatory submissions, and attending regulatory meetings
- Experience in oncology preferred
Responsibilities
- Develop clinical pharmacology and pharmacometric strategies for product development programs
- Lead clinical pharmacology activities for clinical development programs and regulatory interactions
- Perform or oversee modeling and simulation to support drug-development decisions
- Design clinical studies and provide clinical pharmacology input for Phase 1 through Phase 3 studies
- Author and review clinical pharmacology sections of regulatory documents and submissions
- Act as the clinical pharmacology expert in interactions with health authorities
- Collaborate with clinical, translational, preclinical, and due diligence teams
Benefits
- Annual bonus
- Equity compensation
- Comprehensive benefits package