Associate Director, Clinical Pharmacology & DMPK

Summit Therapeutics•Palo Alto, CA

About The Position

The Associate Director, Clinical Pharmacology & DMPK will manage clinical pharmacology, pharmacokinetic (PK), drug metabolism (DM), and data analysis support and operations for Summit’s assets. The role is responsible for pharmacometrics and model-informed drug development (MIDD), including PK, PK/PD, population PK, exposure-response, and model-based meta-analysis (MBMA), to support clinical development programs. It combines hands-on quantitative analyses with strategic scientific contributions to support clinical development, dose optimization, benefit-risk assessment, and regulatory submissions. The Associate Director will collaborate with cross-functional project teams and provide oversight of external pharmacometrics vendors and consultants as appropriate.

Requirements

Ph.D., Pharm.D., or equivalent advanced degree in pharmacometrics, pharmacokinetics, pharmaceutical sciences, pharmacology, biomedical engineering, applied mathematics/statistics, or a related discipline, with 3+ years of relevant pharmaceutical or biotechnology industry experience; or an M.S. with 5+ years of relevant experience.
Demonstrated hands-on quantitative modeling experience and proficiency with pharmacometric software, including NONMEM/PsN, R, and Phoenix WinNonlin, or comparable tools.
Experience applying modeling and simulation to support dose selection or 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 and technical writing, communication, problem-solving, and project management skills, with the ability to work effectively on multidisciplinary teams.

Nice To Haves

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

Responsibilities

Serve as a pharmacometrics subject matter expert on cross-functional project teams and contribute to clinical pharmacology and model-informed drug development strategies.
Independently design, conduct, interpret, and report NCA, PopPK, PK/PD, MBMA, and exposure-response analyses, including data processing, modeling, simulation, visualization, and interpretation.
Develop and apply quantitative models and simulations to support clinical trial design, address drug development questions and program decisions, assess clinically relevant covariates, and evaluate benefit-risk.
Collaborate with Clinical Development, Biostatistics, Statistical Programming, Data Management, Translational Medicine, Regulatory Affairs, and other functions to support appropriate data collection, analysis, and interpretation.
Develop pharmacometric analysis plans and draft analysis reports or relevant sections of regulatory submission documents.
Contribute quantitative analyses and scientific rationale to regulatory interactions and responses to health authority questions.
Provide scientific and technical oversight of external pharmacometrics service providers and consultants, including review of analysis plans, datasets, models, outputs, and reports.
Perform other duties as assigned.