Executive Director, Clinical Operations

Location: On-Site 4 days per week at our Princeton NJ or Miami FL locations

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. 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.

Overview of Role:

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.

Role and 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

Experience Education and Specialized Knowledge and Skills:

• 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

The pay range for this role is $245000 - $307000 annually. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.