Senior Director, Quantitative Clinical Pharmacology Lead

Role Summary

Senior Director, Quantitative Clinical Pharmacology Lead in Cambridge, MA. The role involves managing strategic, scientific and operational aspects of multiple programs from the clinical pharmacology perspective, serving as the Global Clinical Pharmacology Lead for assets across phases 1-4, and providing leadership across R&D partner functions.

Responsibilities

• Provide scientific and strategic leadership as the Clinical Pharmacology Lead for multiple programs on Global Program Teams and associated sub-teams.
• Draft and execute clinical pharmacology plans, including integration of M&S, in collaboration with QS and DMPK; ensure plans enable Model-Informed Drug Development (MIDD).
• Integrate advanced modeling and simulation approaches (e.g., QSP, MBMA) across the development continuum with QS for regulatory interactions.
• Create or assist in protocol synopses; oversee program execution including protocol conduct, data analysis and reporting.
• Prepare clinical pharmacology summary documents (e.g., IB, CTA, CTD Module 2, labeling).
• Oversee PK/PD analyses and statistical analyses in collaboration with external CRO partners.
• Maintain high standards of GCP, compliance and ethics; mentor junior staff.
• Represent Clinical Pharmacology in meetings with global regulatory agencies for assigned programs.
• Participate in Business Development due diligence when required.

Qualifications

• Required: Ph.D. with 16+ years or PharmD with 16+ years, or MS with 18+ years, or BS with 16+ years of experience in pharmacometrics, clinical pharmacology, pharmacokinetics, or related field.
• Preferred: Demonstrated ability to lead across programs and collaborate with cross-functional teams.

Skills

• Clinical pharmacology leadership
• Pharmacometric modeling and simulation (e.g., QSP, MBMA)
• PK/PD analysis and biostatistics collaboration
• Regulatory engagement and documentation (IB, CTA, CTD Module 2)
• GCP compliance and ethical standards
• Mentorship and team development

Education

• Ph.D. or PharmD or MS/BS with extensive experience in pharmacometrics or clinical pharmacology as specified above.

Additional Requirements

• Hybrid work arrangement as per policy.
• Location: Boston, MA (as stated in the description).