Job Title: Executive Director, Clinical Pharmacology

Work Location: Middlesex County, Massachusetts

Summary:

Seeking an experienced leader to provide strategic and scientific direction in the analysis and interpretation of non-clinical and clinical pharmacokinetic (PK), pharmacodynamic (PD), and anti-drug antibody (ADA) data for biologic therapies, supporting dose selection, clinical trial design, and regulatory strategy from pre-clinical through late-stage development.

Responsibilities:

• Lead the development and execution of clinical pharmacology strategies, focusing on PK, ADA, and exposure–response relationships across multiple programs.
• Oversee the analysis, interpretation, and integration of PK and ADA data from rodent, non-human primate, and clinical studies to inform program decisions.
• Guide dose selection and optimization strategies using translational and clinical PK/ADA data to support clinical development.
• Interpret non-clinical PK and immunogenicity data to inform first-in-human starting dose and escalation strategies.
• Act as the clinical pharmacology subject-matter expert on clinical study teams, providing scientific guidance and leadership.
• Design and interpret clinical PK/ADA sampling strategies, including timing, assay considerations, and assessment of immunogenicity impact on PK, efficacy, and safety.
• Author and review clinical pharmacology sections of regulatory documents, including INDs, BLAs, clinical study reports, and investigator’s brochures.
• Collaborate cross-functionally to ensure integrated interpretation of PK and immunogenicity data, supporting clinical and regulatory decision-making.

Qualifications:

• PhD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related discipline (MD or PharmD with relevant experience considered).
• 12+ years of progressive experience with demonstrated program leadership in clinical and non-clinical PK data interpretation, immunogenicity (ADA/NAb) assessment, and biologic drug development.
• Proven track record supporting IND-enabling through late-stage clinical development, including regulatory submissions and agency interactions.
• Expertise in clinical and non-clinical PK, ADA and immunogenicity risk assessment, and exposure–response interpretation.
• Strong understanding of biologic drug disposition and translational PK principles (rodent to NHP to human).
• Excellent scientific writing and data communication skills.
• Demonstrated ability to influence program strategy through data-driven insights and effective cross-functional collaboration.
• Ability to mentor, develop, and scientifically guide team members; high level of accountability, independence, and integrity.

Published Category: Clinical Operations & Development