Senior Clinical Trial Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $158k - $185k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 13%

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2003

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of innovative medicinal therapies aimed at improving quality of life for oncology patients. The company is particularly committed to addressing serious unmet medical needs through its lead investigational therapy, ivonescimab, a novel bispecific antibody designed to target both PD-1 and VEGF. Summit’s initiatives include ongoing Phase III clinical trials to evaluate ivonescimab's effectiveness in treating non-small cell lung cancer, highlighting their dedication to patient-centered care and technological advancement in the field of oncology.

📋 Description

• Provide strategic leadership and operational oversight of complex global clinical trials. • Lead study deliverables at assigned sites, countries, or regions from protocol development support through study closeout and inspection readiness. • Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities. • Serve as the primary operational lead and escalation point for CROs. • Develop and implement patient enrollment, retention, and data quality strategies. • Draft, review, and approve study plans, processes, and documents, including informed consent forms, investigator agreements, CRFs, analysis plans, monitoring plans, data management plans, and safety monitoring activities. • Review and approve essential document packages and critical study deliverables. • Lead Risk Based Quality Management activities and resolve signals and actions. • Review CRO monitoring trip reports, evaluate monitoring quality, identify cross-site trends and risks, and resolve findings and action items. • Perform quality oversight visits focused on inspection readiness. • Lead and review clinical data listings, reports, and dashboards; identify data trends and risks and drive cross-functional resolution. • Oversee Trial Master File maintenance, quality, and completeness and lead TMF quality reviews. • Ensure clinical trial activities comply with Good Clinical Practices and national and international regulatory requirements. • Lead audit and regulatory inspection preparation and support inspection management. • Manage, mentor, and guide CTMs, CRAs, and other Clinical Operations team members. • Drive continuous improvement initiatives and contribute to Clinical Operations processes and standards. • Represent Clinical Operations on cross-functional study teams and governance meetings. • Perform all other duties as assigned.

🎯 Requirements

• Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related areas preferred. • 8–10+ years of clinical operations experience in sponsor pharmaceutical or biotechnology organizations. • 7+ years of direct clinical trial management experience overseeing phase II/III international oncology clinical trials. • Ability to travel internationally to visit clinical sites and study meetings, up to 20% depending on project needs. • Proven capabilities to interpret complex scientific concepts and critically assess clinical data. • Proven proficiency in overseeing large complex studies managed in-house and by a CRO. • Demonstrated ability to problem-solve regarding regulatory requirements, external parties, timelines, and complex clinical programs. • Demonstrated ability to lead teams and work in a fast-paced team environment. • Excellent planning, leadership, communication, negotiation, and organizational skills. • Expert knowledge of the drug development process, ICH guidelines/GCP, and all phases of clinical trial execution. • Ability to apply clinical trial knowledge to complex, global studies.

🏖️ Benefits

• Bonus • Stock • Benefits and/or other applicable variable compensation

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