Associate Director, Clinical Operations

Confirmed live in the last 24 hours

Summit Therapeutics

Compensation

$205,000 USD

Palo Alto, CA (US)

On-site

Posted April 28, 2026

Job Description

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.

Overview of Role:

The Associate Director, Clinical Operations is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. This position is responsible for study start up and maintenance through study close out. The Associate Director, CTM will coordinate, lead and drive Summit’s cross functional team members, CROs, and vendors to successfully deliver clinical studies. They will be responsible for all performance metrics and quality of deliverables in the clinical trial.

Role and Responsibilities:

Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO, and vendors to ensure that overall project objectives are met

Fosters solid professional relationships with key opinion leaders and clinical site staff

Partners with CRO(s) to ensure robust patient enrollment strategies are developed and carried out effectively and on time

Partners with CRO(s) to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data

Proactive identification and management of study related risks

Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements

Responsible for reviewing and managing study related plans, processes including

Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, and safety monitoring

Reviews CRO(s) and vendor contracts/work orders and specifications to enable study objectives to be met

Reviews and approves essential document packages to enable timely site activations

Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report

Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates

Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary

Responsible for oversight on the maintenance of the TMF and completeness at the end of the study

Perform periodic QC of the TMF

Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices (GCP)

Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs

Ensures the study is “inspection ready” always

Responsible for oversight and coaching of the functional activities of Clinical Research Associates and Clinical Trial Associates allocated to the project