Job Title: Senior Director/Executive Director/VP, Clinical Pharmacology

Work Location: Middlesex County, Massachusetts

Summary:

The Senior Director/Executive Director/VP, Clinical Pharmacology will provide scientific and strategic leadership for clinical pharmacology programs, focusing on dose selection, patient stratification, and therapeutic optimization. This role involves oversight of clinical pharmacology studies, data interpretation, and collaboration with cross-functional teams to support clinical development and regulatory submissions.

Responsibilities:

• Direct the design and execution of clinical pharmacology strategies for early- and late-stage clinical studies, including IND, proof-of-concept, and registrational trials.
• Develop and communicate clinical pharmacology plans, including PK/PD modeling, dose selection, and population pharmacokinetic analyses to leadership teams.
• Supervise the collection, processing, and analysis of patient samples to ensure data quality and scientific rigor across clinical programs.
• Collaborate with teams in Drug Metabolism, Translational Medicine, Toxicology, and Biomarkers to design and interpret studies supporting safety and efficacy.
• Oversee bioanalytical assay development, validation, and sample testing at both internal and external laboratories.
• Ensure integration and quality of pharmacology and biomarker datasets to inform clinical decisions and regulatory submissions.
• Represent clinical pharmacology in cross-functional teams, contributing to protocol design, statistical analysis plans, and regulatory documentation.
• Lead the preparation of clinical study reports, investigator brochures, and regulatory filings, and provide scientific input in regulatory interactions.

Qualifications:

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

Published Category: Analytical & Process Development