Associate Director, CMC Statistics at Summit Therapeutics in Princeton, NJ

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. Associate Director, CMC Statistics Job Title: Associate Director, CMC Statistics Department: CMC Location: Princeton, NJ (Onsite; four days per week) Reports To: Executive Director, Analytical Sciences Overview of Role The Associate Director, CMC Statistics, will provide hands-on statistical leadership across Chemistry, Manufacturing, and Controls (CMC) activities. This individual will partner with Analytical Sciences, MSAT, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and external CDMOs/CROs to develop scientifically sound, phase-appropriate, and regulatory-defensible statistical strategies for drug substance and drug product development. The role will be accountable for statistical support of specification setting, stability trending and shelf-life assessment, analytical method bridging and transfer, comparability assessments, method validation, process and product monitoring, investigations, and lifecycle management. The successful candidate will translate complex CMC datasets into clear conclusions, risk assessments, and recommendations that support global regulatory submissions, commercial readiness, and ongoing product control. Role and Responsibilities Serve as the CMC statistical subject matter expert for biologic drug substance and drug product development, registration, commercialization, and lifecycle management. Develop and execute statistical strategies for specification setting, including establishment and justification of release and stability acceptance criteria, control limits, tolerance intervals, and clinically and process-relevant decision rules. Lead statistical evaluation of stability data, including trend analysis, shelf-life and retest-period modeling, protocol design, pooling assessments, extrapolation, and ongoing stability monitoring. Design and analyze analytical method bridging, transfer, qualification, and validation studies; define acceptance criteria and assess equivalence, comparability, precision, accuracy, linearity, range, robustness, and intermediate precision.