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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 strategies supporting product development plans and serve as Clinical Pharmacology lead for programs in clinical development
- Represent the company in regulatory interactions and propose innovative strategies to accelerate therapies to patients
- Perform and/or oversee modeling and simulation to support drug development decisions
- Provide clinical pharmacology input on Phase 1–3 clinical study designs 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
- Interface with clinical study, translational, preclinical, and due diligence teams
- Collaborate with clinical development and discovery functions across end-to-end drug 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
- 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
- Experience responding to regulatory agency questions, preparing clinical pharmacology aspects of regulatory submissions, and attending regulatory meetings
- Experience in oncology is preferred, but not an absolute requirement
- Ability to collaborate with internal and external stakeholders and resolve conflicts
- Highly motivated, decisive, results-oriented, proactive, resourceful, efficient, flexible, and creative
Benefits
Comp & perks- Annual bonus
- Equity compensation
- Comprehensive benefits package
- Periodic travel required
- Accommodations available on request during the selection process