Associate Director, Clinical Operations

Summit Therapeutics, Inc. - Princeton, NJ

Hiring: Associate Director, Clinical Operations Company: Summit Therapeutics, Inc. Location: Princeton, NJ Job Posted Time: 2026-09-10 11:46:21 Employment Type: On-site Target Skills & Keywords : GCP, Quality Assurance, Risk Management About the job Experience: •10+ years of direct clinical trial management experience overseeing phase II/III international oncology clinical trials Required Skills: •Oversees the clinical operational strategy, planning, and execution of one or more global clinical trials. •Ensures internal clinical and external teams deliver on time, within budget and in compliance with GCP, ICH guidelines, applicable regulations and are always inspection-ready. •Drafts, reviews and approves internal and external 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. •Manages CROs, vendors, and strategic partners through robust governance, performance metrics, and risk management. •Identifies operational risks early and implement proactive mitigation strategies escalating to leadership. •Drives financial accountability through effective budget management and resource utilization. •Manages CRO proposals, vendor contracts/change orders, and outsourcing strategies ensuring delivery with a focus on value and return on investment. •Partners with Finance to provide oversight of vendors costs, supporting prudent operational decisions that align with budgets and financial plans. Qualifications: •Oversees maintenance, quality, and completeness of the Trial Master File (TMF) and ensures all TMF quality reviews are completed. Compensation: •$174,000 - $205,000 / year •The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!