Senior Director, Clinical Pharmacology

About the Role

The Senior Director of Clinical Pharmacology will serve as the scientific and strategic leader responsible for the design and execution of clinical pharmacology programs that inform dose selection, patient stratification, and therapeutic optimization. This individual will oversee the planning and delivery of studies supporting early- and late-stage clinical trials, lead data interpretation to guide development decisions, and collaborate closely with Clinical Development, Translational Medicine, Biomarkers, Regulatory Affairs, and Drug Metabolism and Pharmacokinetics. The role also includes oversight of bioanalytical sample strategy, bioanalytical testing, and data integration to support pharmacokinetic (PK), pharmacodynamic (PD), and exposure–response analyses critical for regulatory filings and approval.

Responsibilities

• Lead the design, implementation, and execution of clinical pharmacology strategies across our client's portfolio to support IND, first-in-human, proof-of-concept, and registrational studies.
• Develop, execute and convey to leadership clinical pharmacology plans, including PK/PD modeling, dose selection, and exposure–response analyses, and population pharmacokinetic analysis.
• Oversee collection, processing, and analysis of patient samples across all clinical programs to ensure data quality and scientific integrity.
• Partner with Drug Metabolism and Pharmacokinetics, Translational Medicine, Toxicology, and Biomarkers teams to design and interpret clinical studies supporting mechanism of action, safety, and efficacy.
• Provide scientific and operational oversight for bioanalytical assay development, validation, and sample testing conducted at internal and external laboratories.
• Ensure high-quality data ingestion and integration of pharmacology and biomarker datasets to support clinical decision-making and regulatory submissions.
• Represent Clinical Pharmacology in cross-functional program teams, contributing to protocol design, statistical analysis plans, and regulatory documentation.
• Lead preparation of key sections of clinical study reports, investigator brochures, and regulatory filings (IND, NDA, BLA).
• Provide scientific input and defend clinical pharmacology strategies in interactions with regulatory authorities.

Qualifications

• PhD, PharmD, or MD in Pharmacology, Pharmaceutical Sciences, or a related discipline.
• 10 years of clinical pharmacology experience in the biotech or pharmaceutical industry, including leadership roles in clinical-stage development.
• Demonstrated expertise in clinical pharmacology strategy, study design, and regulatory interactions from early development through registration.
• Deep understanding of PopPK, PK/PD principles, modeling and simulation, and exposure–response analysis.
• Proven experience overseeing patient sample management, bioanalytical testing, and assay validation.
• Strong cross-functional leadership and ability to integrate complex scientific data into strategic development decisions.
• Excellent communication skills, with the ability to present to senior leadership and external stakeholders.
• Oncology experience.