Associate Director, Clinical Operations

atSummit Therapeutics, Inc.Remote

United States Full-time Clinical OperationsSenior$170k – $198k/year

Posted Sep 14

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide leadership for the operational execution of clinical trials.

• Supervise the clinical operations team and monitor vendor performance.

• Direct operational strategy, planning, and execution for one or multiple global clinical trials.

• Ensure that both internal and external teams meet deadlines, stay within budget, and comply with GCP, ICH guidelines, and relevant regulations.

• Develop, review, and approve plans, processes, and documents related to the study.

• Manage CROs, vendors, and strategic partners through governance, performance metrics, and risk management.

• Identify operational risks and implement strategies for mitigation, escalating issues to leadership as needed.

• Oversee budgets, resources, vendor costs, proposals, contracts, change orders, and outsourcing strategies.

• Ensure maintenance, quality, completeness, and reviews of the Trial Master File.

• Prepare for and provide support during regulatory inspections.

• Manage, mentor, and guide Clinical Trial Managers (CTMs), Clinical Research Associates (CRAs), and members of the Clinical Operations team.

• Drive continuous improvement and contribute to the processes and standards within Clinical Operations.

• Represent Clinical Operations in cross-functional study teams and governance meetings.

• Collaborate with teams in Regulatory Affairs, Clinical Science, Data Management, Biostatistics, Pharmacovigilance, Quality Assurance, CMC, Commercial, and external partners.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor’s degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology, or other health/medical-related fields.

• Over 10 years of direct experience in clinical trial management, particularly overseeing phase II/III international oncology clinical trials.

• Willingness to travel internationally for clinical site visits and study meetings, up to 20% of the time.

• Strong problem-solving skills and the ability to exercise sound judgment regarding regulatory requirements, interactions with external parties, timelines, and complex clinical programs.

• Exceptional planning, leadership, communication, negotiation, and organizational abilities.

• In-depth knowledge of the drug development process, ICH guidelines/GCP, and all phases of clinical trial execution.

• Capability to apply clinical trial expertise to complex global studies.