Associate Director, Clinical Operations

🔥 15 minutes ago

🇺🇸 United States – Remote

💵 $170k - $198k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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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 operational leadership for clinical trial execution • Oversee the clinical operations team and vendor performance • Lead operational strategy, planning, and execution for one or more global clinical trials • Ensure internal and external teams deliver on time, within budget, in compliance with GCP, ICH guidelines, and applicable regulations • Draft, review, and approve study-related plans, processes, and documents • Manage CROs, vendors, and strategic partners through governance, performance metrics, and risk management • Identify operational risks and implement mitigation strategies, escalating to leadership • Manage budgets, resources, vendor costs, proposals, contracts, change orders, and outsourcing strategies • Oversee Trial Master File maintenance, quality, completeness, and reviews • Prepare for and support regulatory inspections • Manage, mentor, and guide CTMs, CRAs, and Clinical Operations team members • Drive continuous improvement and contribute to Clinical Operations processes and standards • Represent Clinical Operations on cross-functional study teams and governance meetings • Collaborate with Regulatory Affairs, Clinical Science, Data Management, Biostatistics, Pharmacovigilance, Quality Assurance, CMC, Commercial, and external partner teams • 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 • 10+ 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% • Ability to solve problems and use clear judgment in relation to regulatory requirements, external-party interactions, timelines, and complex clinical programs • 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 • Other applicable variable compensation • Equal opportunity employment