Senior/Executive Director, Clinical Pharmacology Lead

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Serve as both the Head of Clinical Pharmacology and Clinical Pharmacology SME/Lead across multiple programs, on both the oncology and immunology side, setting and owning the execution of clinical pharmacology plans from IND through early clinical development (POC).
• Design and oversee PK, PD, and exposure-response analyses to support dose selection, study design, and benefit-risk assessments.
• Propose and lead the development and execution of clinical pharmacology components of studies, including food effect, drug-drug interaction, organ impairment, and QT assessments.
• Author and review clinical pharmacology sections of regulatory documents (e.g., INDs, NDAs, briefing books) and support regulatory interactions.
• Collaborate with Translational Medicine and Biomarker teams to integrate mechanistic and biomarker data into PK/PD interpretation.
• Work closely with Biometrics and external modeling partners to support population PK and exposure-response modeling.
• Contribute to program-level planning and prioritization based on pharmacological insights and development risk.

REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES

• M.D., Pharm.D., or equivalent in Clinical Pharmacology, Pharmaceutical Sciences, or a related field.
• 12+ years of experience in clinical pharmacology and/or pharmacometrics in the biotech or pharmaceutical industry.
• Direct experience designing and executing early-phase clinical studies, including healthy volunteer studies.
• Strong expertise in PK analysis and exposure-response interpretation; experience in oncology or immnology preferred.
• Experience managing external Clinical Pharmacology resources.
• Proven track record of contributing to regulatory submissions and engaging with health authorities.
• Excellent communication, collaboration, and organizational skills.
• Ability to work independently and in a fast-paced, matrixed environment.
• Ability to travel up to 15%.