Associate Director, CMC / Quality Project Management

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. The Associate Director, Project Management (CMC, Quality) is an individual contributor position that will play a critical role in driving the success of Summit programs and with prioritized focus in CMC, Supply, Quality and Business activities.  Role will provide CMC / Quality program leadership in cross-functional team settings and will help build the infrastructure, tools and processes contributing to the success of Program Management department. Provides strategic and operational leadership for CMC and Quality deliverables across the biologics development lifecycle—from early clinical phases through BLA submission and post‑approval changes. Working within a matrixed environment, you will collaborate across Process Development, Analytical Development, Quality, Regulatory Affairs, Manufacturing, external partners (CDMOs/CROs) to deliver high-quality submissions and commercialization readiness. If you enjoy the excitement and intensity of senior leader engagements where assignments may deeply embed you with targeted functions or teams, then this is the role for you!  Role and Responsibilities: Cross-functional Collaboration and CMC Leadership Represent the Program Management department in cross-functional teams with clinical development, non-clinical and/or regulatory focus Develop and maintain detailed CMC submission plans, timelines, and risk mitigation strategies for BLA and other regulatory filings Prepare high-impact presentations, decision memos, and status reports for senior management and governance forums Implement and refine program tools, workflows, and processes to enhance efficiency, transparency, and quality of CMC operations Strategic Responsibilities: Ensure alignment in CMC strategy for early stage IND/IMPD and late-stage biologics suitable for BLA/ MAA filings (including characterization, control strategy, comparability, stability, regulatory expectations) Ensure alignment of CMC deliverables with project milestones and product target profile through data-driven and risk-based decision-making Engage in cross-functional governance and steering committees to influence and guide program direction. Project Management Maintain decision-quality approaches within assigned areas with options and trade-off assessments Actively identify, track and mitigate risks, to include opportunity creation that may accelerate project success              Develop, implement and maintain CMC plans for assigned activities, to include scenario planning, dashboards, reports and timelines that integrate into overall Program Plans. Communicate CMC plans to cross-functional team and leadership Provide clinical supply inputs to development scenarios, clinical supply forecast, vendor plans, and governance decisions, balancing patient needs, operational feasibility, cost, inventory, expiry, and supply risk. Support clinical trial start-up and execution by tracking critical supply dependencies and ensuring timely escalation of issues that could affect first-patient-in, site activation, enrollment, dosing continuity. CDMO/CMO Oversight & External Collaboration Management Serve as the primary CMC PM interface for CDMOs/CMOs performing drug substance, drug product, and analytical testing. Monitor CDMO performance against KPIs (batch production and release, deviation closure, CAPA effectiveness) and escalate risks proactively. Serve as the CMC/Supply PM liaison for external study collaborations, integrating partner assumptions and timelines into internal program plans; facilitate cross-company risk reviews, scenario assessments, issue resolution, and governance decisions to maintain alignment on study readiness and continuity of clinical supply. Lead CMC and clinical supply program management for collaborative clinical studies with external partners, establishing joint plans, governance cadence, roles, decision rights, milestones, dependencies, deliverables, and escalation pathways aligned with contractual obligations and