Head, Project Management

Head, Project Management & Program Management Apply for the Head, Project Management & Program Management role at Summit Therapeutics, Inc. Location: This role can be based on-site in Miami, FL - Menlo Park, CA - or Princeton, NJ. About Summit: Ivonescimab, also known as SMT112, is a novel, potential first?in?class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti?angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD?1 and VEGF. Summit has begun its clinical development of ivonescimab in non?small cell lung cancer (NSCLC), with three active Phase III trials: HARMONi - Phase III evaluating ivonescimab combined with chemotherapy versus placebo plus chemotherapy in EGFR?mutated locally advanced or metastatic non?squamous NSCLC after 3rd generation EGFR TKI. HARMONi?3 - Phase III evaluating ivonescimab combined with chemotherapy versus pembrolizumab combined with chemotherapy in first?line metastatic NSCLC. HARMONi?7 - Phase III evaluating ivonescimab monotherapy versus pembrolizumab monotherapy in first?line metastatic NSCLC with high PD?L1 expression. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summits license territories, including the United States and Europe. It was approved for marketing authorization in China in May 2024 and granted Fast Track designation by the US FDA for the HARMONi clinical trial setting. Overview of Role Reporting to the Chief Business & Strategy Officer, the Head of Project Management & Program Management will lead the project management office (PMO) responsible for cross?functional strategic and operational execution of development and ultimate regulatory approval and commercialization of ivonescimab. The leader will drive cross?functional alignment, ensure delivery of clinical development plans from Phase I through Phase III, and support regulatory filings including BLA, MAA, and other global submissions. Role and Responsibilities Lead a high?performing Project Management Office that supports strategic planning and execution across all development programs. Oversee and define the integrated program plan covering Phase I?III trials and regulatory filings. Lead cross?functional teams including Clinical, Regulatory, Medical Affairs, CMC, Operations, and Commercial to align on strategy, resolve issues, and drive execution. Oversee planning and execution of multiple clinical trials, ensuring readiness for regulatory filings and inspection preparedness. Facilitate decision?making processes, including risk mitigation strategies, plan amendments, and scenario planning. Present updates, risks, and strategic recommendations to the Executive Leadership Team and other senior stakeholders regarding ivonescimab. Mentor and develop project managers and program leads, fostering a culture of accountability, innovation, and continuous improvement. Drive strategic alignment for development, research, manufacturing, regulatory, medical affairs, market access, pricing and commercialization plans. All other duties as assigned. Experience, Education and Specialized Knowledge and Skills Advanced Degree (Ph.D., M.D., Pharm.D., MBA, or applicable masters degree) with at least 15+ years of pharmaceutical/biotech industry experience, including leadership experience in program management or similar function. Proven leadership in project management and program management across Phase I?III clinical trials. Experience in cross?functional team leadership, including strategy development and driving tactical delivery of programs. Strong experience in drug development and late?stage registration required; oncology experience strongly preferred. Deep understanding of regulatory pathways and commercialization strategies. Exceptional communication, negotiation, and stakeholder management skills. Compensation The pay range for this role is $300,000-$350,000 annually. Actual compensation packages are based on factors including skill set, depth of experience, certifications, and specific work location, and may include bonus, stock, benefits, or other variable compensation. #J-18808-Ljbffr