Senior Clinical Trial Manager

Job not on LinkedIn

🔥 42 minutes ago

🇺🇸 United States – Remote

💵 $158k - $185k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2003

🏥 Healthcare

💼 Consulting

📣 Marketing

🔥 Funding within the last year

💰 $500M Post-IPO Equity - Summit Therapeutics on 2025-10

Healthcare • Consulting • Marketing

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of novel medicinal therapies to improve quality and duration of life for patients with serious unmet medical needs. The company is advancing ivonescimab (SMT112), a novel bispecific antibody targeting PD-1 and VEGF, through multiple Phase 3 clinical trials for non-small cell lung cancer and other solid tumors under license from Akeso. Summit emphasizes clinical development, regulatory filing strategies, and potential commercialization in its licensed territories while promoting patient- and caregiver-friendly treatment options.

📋 Description

• Provide strategic leadership and operational oversight for complex global clinical trials. • Lead study deliverables across assigned sites, countries, or regions from protocol development support through closeout and inspection readiness. • Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout. • Serve as primary operational lead and escalation point for CROs. • Develop and implement patient enrollment, retention, data quality, and monitoring 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, actions, risks, and trends. • Oversee CRO monitoring activities and review monitoring trip reports. • Perform quality oversight visits focused on inspection readiness. • Lead review of clinical data listings, reports, and dashboards; identify trends and risks and drive cross-functional resolution. • Oversee Trial Master File maintenance, quality, completeness, and 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 personnel. • Drive continuous improvement and contribute to Clinical Operations processes and standards. • Represent Clinical Operations on cross-functional study teams and governance meetings. • Perform 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. • Ability to interpret complex scientific concepts and critically assess clinical data. • Proficiency overseeing large, complex studies managed in-house and by a CRO. • Ability to problem-solve regarding regulatory requirements, external parties, timelines, and complex clinical programs. • 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, and GCP. • Deep understanding of all phases of clinical trial execution and ability to apply this knowledge to complex global studies.

🏖️ Benefits

• Bonus • Stock • Benefits • Potential variable compensation • International travel opportunities (up to 20%)