Associate Director, Clinical Pharmacology & DMPK at Summit Therapeutics in Palo Alto, CA

Job description

About Summit: 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. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. 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 servic