Overview 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. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are the heart and soul of our culture and are invaluable in shaping our journey toward excellence. Summit’s team conducts clinical studies in oncology and has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 study evaluating ivonescimab with chemotherapy versus placebo with chemotherapy in EGFR-mutated, locally advanced or metastatic non-squamous NSCLC previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 study evaluating ivonescimab with chemotherapy versus pembrolizumab with chemotherapy in first-line metastatic NSCLC. HARMONi-7: Phase 3 study evaluating ivonescimab monotherapy versus pembrolizumab monotherapy in first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 study evaluating ivonescimab in combination with chemotherapy versus bevacizumab with 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, with offices in California, New Jersey, the UK, and Ireland. Role and Responsibilities Oversee study scope, quality, timelines, and budget with internal Summit leads, CROs, and vendors to ensure objectives are met. Foster professional relationships with key opinion leaders and clinical site staff. Partner with CROs to develop and execute robust patient enrollment strategies and data monitoring plans. Identify and manage study-related risks proactively. Develop and manage clinical trial documents (protocols, CRFs, consent documents, confidentiality agreements). Review and manage study plans and processes including investigator agreements (CTA), CRF guidelines, analysis plans, monitoring, data management, and safety monitoring. Review CRO/vendor contracts and specifications to enable study objectives to be met. Review and approve essential document packages to enable timely site activations. Provide oversight on study monitoring visits and closeout reports; address findings with broader team. Direct investigator performance and adherence to protocol; address conduct issues and enrollment challenges as needed. Maintain TMF and confirm completeness at study end; perform periodic TMF QC. Oversee clinical trial activities in accordance with Good Clinical Practices (GCP) and ensure regulatory compliance; keep trials inspection-ready. Oversee coaching of Clinical Research Associates (CRAs) and Clinical Trial Associates allocated to the project. All other duties as assigned. Experience, Education and Specialized Knowledge and Skills Bachelor’s degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology, or related area preferred. 10+ years of clinical project management experience in international trials in sponsor Pharma/Biotech. Minimum 2+ years of phase II and III combined experience. Strong understanding of drug development, ICH guidelines/GCP, and all steps in the clinical trial process. Experience with budget forecasting and management. Experience with oncology studies strongly preferred. Ability to travel internationally to sites and meetings (up to 20%). Proven proficiency in overseeing large complex studies managed in-house and with CROs. Experience leading teams in a fast-paced environment; line management experience preferred. Ability to delegate and manage others; demonstrated people-management or matrix management. Proven track record building relationships with KOLs and site personnel; ability to collaborate with overseas teams. Ability to develop and execute patient enrollment strategies. Excellent interpersonal and decision-making skills; demonstrated drive and enthusiasm to meet objectives. Ability to comprehend and communicate complex scientific concepts and data; proficient in reviewing and assessing clinical data. Excellent planning, time management, and coordination skills; strong attention to detail and confidentiality. Ability to multi-task and manage time-sensitive, confidential documents; proficient in MS Office and document management tools desirable. Pay and Benefits Pay: $175,000 — $205,000 USD. Actual compensation is based on candidate’s skills, experience, certifications, and location; may include bonus, stock, benefits, and other variable compensation. Summit does not accept referrals from employment businesses/agencies for vacancies. All agencies must contact Summit’s Talent Acquisition team for prior written authorization before referring candidates. EEO Statement: Summit Therapeutics Inc. is an Equal Opportunity Employer and maintains a diverse environment. We do not discriminate based on race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. #J-18808-Ljbffr