Clinical Pharmacology Lead

Job Summary

Providing strategic leadership for Clinical Pharmacology activities, the full-time remote Clinical Pharmacology Lead will oversee the execution of Clinical Pharmacology strategies, regulatory deliverables, and support for late-stage development and registration activities within the transplant portfolio.

Key responsibilities

• Represent Clinical Pharmacology on program and study teams, influencing key program decisions and strategic direction
• Develop and execute integrated Clinical Pharmacology strategies for dose selection, benefit-risk assessment, and regulatory approval
• Lead preparation of Clinical Pharmacology components for major regulatory submissions and manage interactions with health authorities

Required qualifications

• PhD, PharmD, MD, or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics, Clinical Pharmacology, or a related discipline
• 8+ years of relevant industry experience with substantial exposure to late-stage development and regulatory submissions
• Demonstrated experience as a Clinical Pharmacology Lead for development programs, including accountability for strategy and execution
• Proven track record in authoring Clinical Pharmacology sections of BLAs, NDAs, or equivalent regulatory submissions
• Deep expertise in dose justification, exposure-response evaluation, and Model-Informed Drug Development approaches