Associate Director, Clinical Operations

About Summit:

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. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people.

Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:

Non-small Cell Lung Cancer (NSCLC)
HARMONi:
Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.HARMONi-3:
Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.HARMONi-7:
Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.Colorectal Cancer (CRC)
HARMONi-GI3:
Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

ASSOCIATE DIRECTOR, CLINICAL OPERATIONS

Location:

Princeton, NJ or Miami, FL ONSITEOverview of 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. This role leads vendor strategy and oversight ensuring external partners deliver against scope, timelines, quality expectations, and operational objectives.

The ideal candidate thrives in a fast-paced, entrepreneurial environment, demonstrates exceptional operational leadership, and possesses strong business acumen with an understanding of the competitive landscape, capital allocation, and value creation throughout drug development.

Role and 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 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.

Oversees maintenance, quality, and…