Executive Director, Clinical Operations

Summit Therapeutics Sub•Princeton, NJ

1d•$245,000 - $307,000•Onsite

About The Position

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. Summits 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. Summits team is inspired to touch and help change lives through Summits 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 Chinas National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. We are seeking a hands-on Executive Director, Clinical Operations to lead global execution of multiple Phase IIIII clinical trials in oncology (non-lung) within a fast-paced biotech startup environment. This role has end-to-end accountability for clinical trial delivery and for building, leading, and developing a high-performing global Clinical Operations organization, including direct management of the Study Start-Up (SSU) team, line management of direct reports, and oversight of external service providers.

Requirements

Bachelors degree in life sciences (advanced degree preferred)
Minimum of 15+ years of clinical operations expertise spanning biotech, pharma, and CRO organizations, with the last decade dedicated to overseeing complex phase III oncology trials from startup through completion
Proven track record of successfully managing direct reports and leading cross-functional teams through influence in a matrixed environment
Demonstrated leadership over the last decade by managing teams exceeding 20 direct and skip-level reports, driving performance, development, and organizational alignment.
Proven leadership of multiple global Phase IIIII trials
Strong experience in CRO governance, including oversight frameworks, KPIs, risk escalation, and quality monitoring
Experience overseeing unblinded monitoring models and external service providers
Experience in SOP development, review, and implementation
Deep knowledge of ICH, GCP, and global clinical trial regulations
Strong experience with site budgets, contracts, CRO oversight, and vendor management
Ability to operate strategically while remaining hands-on and execution-focused
Demonstrated experience in process improvement and the application of technology to streamline clinical operations.
High-quality executor; ability to execute against goals and milestones with quality, precision, and speed
Ability to operate effectively in a fast-paced, resource-conscious global startup environment
Willingness to travel internationally as needed

Responsibilities

Lead global execution of multiple Phase IIIII clinical trials in oncology (non-lung)
Build, manage, mentor, and provide line management for Clinical Operations staff (>20 members with skip reports), including study management team leaders, clinical trial managers, CRAs and contractors
Directly manage the global Study Start-Up team, overseeing essential documents, site budgets, and site contract negotiations
Establish and drive SSU performance metrics, including site activation cycle times, essential document completeness, and budget and contract turnaround time
Monitor progress, enrollment, quality, timelines, and budgets across multiple concurrent studies; proactively manage risks
Timely escalation of risks to the Head of Clinical Operations.
Lead CRO governance, including selection, contracting, performance monitoring, KPIs, risk management, escalation pathways, and executive reviews to ensure quality, timelines, and budget adherence
Manage and oversee Randstad Services providing unblinding monitoring support, ensuring compliance, quality, timelines, and clear separation of blinded and unblinded activities
Partner cross-functionally with Clinical Development, Medical Affairs, Regulatory, Biometrics, Safety, CMC, Quality, and Project Management across regions
Support SOP development, review, and implementation to ensure consistency, compliance, and inspection readiness across clinical operations
Support preparation of clinical components for global regulatory submissions and health authority inspections
Implement fit-for-purpose global clinical operations processes, metrics, and oversight models appropriate for a growing biotech company
Partner with Business Operations and IT to identify and implement technological solutions to replace manual processes and improve data transparency.
All other duties as assigned