Associate Director, Clinical Pharmacology

About the role

This role provides expertise and support for the design, execution, interpretation, and reporting of clinical pharmacokinetic/pharmacodynamic (PK/PD) studies. The Clinical Pharmacology Associate Director will participate in the selection of Phase 1 CROs, ensure adequate preclinical characterization, and support the clinical pharmacology profile of compounds. They will also ensure the CP strategy and plans fully support dose selection and regimen for Phase 1, 2, and 3 studies. The individual will serve as the CP representative on studies and project teams, contribute to regulatory filings, and present PK/PD data to internal and external stakeholders. Additionally, they may oversee pharmacometric analyses and mentor less experienced staff.

Responsibilities

• Act as the CP representative, providing expertise to multidisciplinary study teams for early and late-stage clinical and lifecycle management projects.
• Support the design and interpretation of Phase 1 and other clinical studies with PK or PK/PD data.
• Perform non-compartmental analysis of PK data and ensure appropriate PK-PD analysis, including population PK or PK/PD modeling and simulation.
• Contribute to the design of clinical study protocols and review clinical study reports.
• Participate in the selection of Phase 1 CROs.
• Support dose selection for Phase 1, 2, and 3 clinical studies.
• Collaborate with preclinical teams, statisticians, clinical operations, medical directors, regulatory affairs, and other internal/external partners to ensure timely completion of studies and filings.
• Represent the CP group on multi-disciplinary study/project teams.
• Contribute CP-related components to regulatory documents (INDs, NDAs, IBs).
• Serve as the Clinical Study Lead for all Clinical Pharmacology/Phase 1 studies.

Qualifications

• PhD or PharmD degree in Pharmaceutical Sciences or a related discipline.
• At least 7 years of industry experience with a proven track record in PK and PD.
• Previous experience leading CP programs.
• Highly skilled in compartmental/non-compartmental analyses.
• Working knowledge of NONMEM and R (preferred).
• Excellent writing and verbal communication skills.
• Ability to work in a matrix environment and adapt to different leadership styles.
• Ability to work independently, proactively, and effectively.
• Strong multitasking and adaptability to change.
• Maintains composure under pressure.
• Ability to follow verbal or written instructions and communicate effectively.
• Quick grasp of new information and attention to detail.