Work Location: Middlesex County, Massachusetts

Summary:

Seeking a scientific and strategic leader to oversee the design and execution of clinical pharmacology programs, focusing on dose selection, patient stratification, and therapeutic optimization for oncology drug development. This role involves cross-functional collaboration, data integration, and regulatory support for early- and late-stage clinical trials.

Responsibilities:

• Direct the planning and execution of clinical pharmacology strategies for investigational and registrational studies.
• Develop and communicate clinical pharmacology plans, including PK/PD modeling, dose selection, and exposure–response analyses.
• Supervise the collection, processing, and analysis of patient samples to ensure data quality and scientific rigor.
• Collaborate with multidisciplinary teams to design and interpret studies supporting mechanism of action, safety, and efficacy.
• Oversee bioanalytical assay development, validation, and sample testing at both internal and external laboratories.
• Ensure integration of pharmacology and biomarker datasets to support clinical decision-making and regulatory submissions.
• Represent clinical pharmacology in cross-functional teams, contributing to protocol design, statistical analysis, 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.
• 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.
• Oncology experience required.

Published Category: Clinical Research