Associate Director, Clinical Pharmacology & DMPK

The role

The Associate Director, Clinical Pharmacology & DMPK will manage clinical pharmacology, pharmacokinetic, drug metabolism, and data analysis supports for Summit's assets. This role involves hands-on quantitative analyses and strategic scientific contribution to support clinical development, dose optimization, and regulatory submissions.

What you will do

• Serve as a pharmacometrics subject matter expert on cross-functional project teams.
• Design, conduct, interpret, and report NCA, PopPK, PK/PD, MBMA, and exposure-response analysis.
• Develop and apply quantitative models and simulations to support clinical trial design and program decisions.
• Collaborate cross-functionally with Clinical Development, Biostatistics, Statistical Programming, Data Management, Translational Medicine, and Regulatory Affairs.
• Develop pharmacometric analysis plans and draft analysis reports or regulatory submission sections.
• Contribute quantitative analyses and scientific rationale to regulatory interactions.
• Provide scientific and technical oversight of external pharmacometrics service providers and consultants.
• All other duties as assigned.

Required qualifications

• Ph.D., Pharm.D., or equivalent advanced degree in pharmacometrics, pharmacokinetics, pharmaceutical sciences, pharmacology, biomedical engineering, applied mathematics/statistics, or a related discipl
• Demonstrated hands-on quantitative modeling experience.
• Proficiency with pharmacometric software, including NONMEM/PsN, R, and Phoenix WinNonlin, or comparable tools.
• Experience applying modeling and simulation to support dose selection/optimization, clinical trial design, benefit-risk assessment, and development decision-making.
• Experience drafting pharmacometric and clinical pharmacology analysis reports and supporting regulatory submissions.
• Working knowledge of drug development and applicable FDA, ICH, and other regulatory expectations for clinical pharmacology and pharmacometrics.
• Strong scientific, technical writing, communication, problem-solving, and project management skills.

Nice to have

• Experience contributing to responses to regulatory agency questions
• Experience managing external pharmacometrics vendors, CROs, or consultants

Benefits

• bonus
• stock
• benefits
• other applicable variable compensation

About the company

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.