Associate Director, Clinical Operations

About the company

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and commitment to people. The company is currently conducting multiple global Phase 3 clinical studies in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), including:

• HARMONi: Phase 3 study evaluating ivonescimab combined with chemotherapy vs. placebo plus chemotherapy in EGFR-mutated, locally advanced or metastatic non-squamous NSCLC after third-generation EGFR TKI treatment.
• HARMONi-3: Phase 3 study evaluating ivonescimab combined with chemotherapy vs. pembrolizumab combined with chemotherapy in first-line metastatic NSCLC.
• HARMONi-7: Phase 3 study evaluating ivonescimab monotherapy vs. pembrolizumab monotherapy in first-line metastatic NSCLC.
• HARMONi-GI3: Phase 3 study evaluating ivonescimab in combination with chemotherapy vs. bevacizumab plus chemotherapy in colorectal cancer.

Ivonescimab is an investigational therapy currently approved only by China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland.

About the role

The Associate Director, Clinical Operations provides operational leadership for clinical trial execution, overseeing the clinical operations team and vendor performance. This role ensures effective study delivery through cross-functional collaboration, proactive risk management, and strong execution oversight. The ideal candidate thrives in a fast-paced, entrepreneurial environment and demonstrates exceptional operational leadership with strong business acumen.

Responsibilities

• 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 inspection readiness.
• 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 implements proactive mitigation strategies, escalating to leadership as needed.
• Drives financial accountability through effective budget management and resource utilization.
• Oversees maintenance, quality, and completeness of the Trial Master File (TMF) and ensures all TMF quality reviews are completed.
• Manages CRO proposals, vendor contracts/change orders, and outsourcing strategies with a focus on value and return on investment.
• Partners with Finance to provide oversight of vendor costs, supporting prudent operational decisions aligned with budgets and financial plans.
• Oversees preparations for regulatory inspections, supports inspection management activities, and ensures the project is always inspection-ready.
• Manages, mentors, and provides guidance to CTMs, CRAs, and other Clinical Operations team members.
• Drives continuous improvement initiatives and contributes to the development of Clinical Operations processes and standards.
• Represents Clinical Operations on cross-functional study teams and governance meetings.
• Fosters collaboration with external partners, Regulatory Affairs, Clinical Science, Data Management, Biostatistics, Pharmacovigilance, Quality Assurance, CMC, and Commercial teams.
• Performs 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%).

Preferred Qualifications

• Consistently demonstrates ability to solve problems and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
• Excellent planning, leadership, communication, negotiation, and organizational skills when working with both internal and external teams.
• Expert knowledge of the drug development process, ICH guidelines/GCP, with a deep understanding of all phases of clinical trial execution and the ability to apply this knowledge to complex, global studies.

Pay

$174,000 - $205,000 USD. Actual compensation packages are based on factors unique to each candidate, including skill set, depth of experience, certifications, and specific work location. The total compensation package may also include bonus, stock, benefits, and/or other applicable variable compensation.