Senior Clinical Trial Manager at Summit Therapeutics

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 Senior Clinical Trial Manager (Sr. CTM) is a highly experienced clinical operations professional responsible for providing strategic leadership and operational oversight of complex global clinical trials coordinates, while leading and driving deliverables at assigned sites, countries or regions. The Sr. CTM is accountable for all aspects of study execution from protocol development support through study closeout and inspection readiness. The Sr. CTM may manage multiple studies or programs simultaneously and provides mentorship and guidance to Clinical Trial Managers and other Clinical Operations personnel. Role and Responsibilities: Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities. Oversees and provides strategic leadership to site selection, feasibility, enrollment, monitoring issue escalation and close out activities. and operational oversight for global clinical trials from study start-up through closeout. Serves as the primary operational lead and escalation point for CROs, ensuring high-quality study execution, data monitoring strategies and enrollment strategies by developing and implementing strong patient enrollment, retention, and data quality strategies. Drafts, reviews and approves study-related plans, processes, and documents including Informed Consent Forms, Investigator Agreements (CTA), CRFs, CRF Guidelines, statistical/pharmacokinetic analysis plans, monitoring plans, data management plans, and safety monitoring activities. Reviews and approves essential document packages and critical study deliverables. Leads Risk Based Quality Management activities and ensures timely resolution of signals and actions. Ensuring study performance metrics and proactively identifies risks, trends, and mitigation strategies. Leads sponsor oversight of CRO monitoring activities by reviewing monitoring trip reports; evaluates monitoring quality, identifies cross site trends and risks, and drives timely resolution of critical findi