Executive Director, Clinical Pharmacology/Pharmacometrics

Highlights

• Lead clinical pharmacology strategy for rare disease and oncology programs.
• Drive modeling and simulation to accelerate dose selection and decisions.
• Serve as clinical pharmacology expert for global health authority interactions.

Ideal candidate

A decisive, collaborative drug development leader with 10+ years driving clinical pharmacology strategy who thrives in fast-growing biotech and is passionate about delivering therapies to patients with devastating diseases.

Requirements

• Ph.D. in Pharmaceutical Sciences, Pharmacokinetics or related discipline, M.D. with Clinical Pharmacology expertise, or PharmD with Clinical Pharmacology fellowship
• 10+ years of experience in biotech/pharmaceutical drug development
• Demonstrated success leading all clinical pharmacology aspects of drug development
• Experience managing PK, PK-PD and PK-safety analyses including NCA, population PK and PK-PD modeling and simulation
• Proficiency with WinNonlin, Monolix, NONMEM, R or other modeling software
• Demonstrated experience responding to regulatory agency questions and preparing clinical pharmacology sections of submissions
• Experience attending regulatory meetings and acting as clinical pharmacology expert
• Experience in oncology preferred