Associate Director, Clinical Pharmacology & DMPK

Overview of Role: 

The Associate Director, Clinical Pharmacology & DMPK will manage clinical pharmacology, pharmacokinetic (PK), drug metabolism (DM) and data analysis supports and operation for Summit’s assets. This role is responsible for pharmacometrics, model-informed drug development (MIDD), including PK, PK/PD, population PK, exposure-response, and Model-based meta-analysis (MBMA) to support Summit’s clinical development programs.  

This role will combine hands-on quantitative analyses with strategic scientific contribution to support clinical development, dose optimization, benefit-risk assessment, and regulatory submissions. 

The individual will collaborate closely with cross-functional project teams and provide oversight of external pharmacometrics vendors and consultants, as appropriate. 

Role and 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, Model-based meta-analysis (MBMA), and exposure-response analysis, including hands-on data processing, modeling, simulation, visualization, and interpretation. 
• Develop and apply quantitative models and simulations to support clinical trial design, address key drug development questions and support program decisions, assessment of clinically relevant covariates, and benefit-risk evaluation. 
• Collaborate cross-functionally 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 in 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. 
• All other duties as assigned. 
• All other duties as assigned 

 
Experience, Education and Specialized Knowledge and Skills: 

• 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/biotechnology industry experience; or 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/optimization, clinical trial design, benefit-risk assessment, and development decision-making. 
• Experience drafting pharmacometric and clinical pharmacology analysis reports and supporting regulatory submissions. Experience contributing to responses to regulatory agency questions is preferred. 
• Working knowledge of drug development and applicable FDA, ICH, and other regulatory expectations for clinical pharmacology and pharmacometrics. 
• Experience managing external pharmacometrics vendors, CROs, or consultants is preferred. 
• Strong scientific, technical writing, communication, problem-solving, and project management skills, with the ability to work effectively on multidisciplinary teams.