Executive Director, Clinical Operations

Location: On-Site 4 days per week at our Princeton, NJ or Miami FL locationsAbout 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: We are seeking a hands-on Executive Director, Clinical Operations to lead global execution of multiple Phase II–III 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 II–III 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 contractorsDirectly manage the global Study Start-Up team, overseeing essential documents, site budgets, and site contract negotiationsEstablish and drive SSU performance metrics, including site activation cycle times, essential document completeness, and budget and contract turnaround timeMonitor progress, enrollment, quality, timelines, and budgets across multiple concurrent studies; proactively manage risksTimely 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 adherenceManage and oversee Randstad Services providing unblinding monitoring support, ensuring compliance, quality, timelines, and clear separation of blinded and unblinded activitiesPartner cross-functionally with Clinical Development, Medical Affairs, Regulatory, Biometrics, Safety, CMC, Quality, and Project Management across regionsSupport SOP development, review, and implementation to ensure consistency, compliance, and inspection readiness across clinical operationsSupport preparation of clinical components for global regulatory submissions and health authority inspectionsImplement fit-for-purpose global clinical operations processes, metrics, and oversight models appropriate for a growing biotech companyPartner with Business Operations and IT to identify and implement technological solutions to replace manual processes and improve data transparency.All other duties as assignedExperience, Education and Specialized Knowledge and Skills: Bachelor’s 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 completionProven track record of successfully managing direct reports and leading cross-functional teams through influence in a matrixed environmentDemonstrated 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 II–III trialsStrong experience in CRO governance, including oversight frameworks, KPIs, risk escalation, and quality monitoringExperience overseeing unblinded monitoring models and external service providersExperience in SOP development, review, and implementationDeep knowledge of ICH, GCP, and global clinical trial regulationsStrong experience with site budgets, contracts, CRO oversight, and vendor managementAbility to operate strategically while remaining hands-on and execution-focusedDemonstrated 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 speedAbility to operate effectively in a fast-paced, resource-conscious global startup environmentWillingness to travel internationally as neededThe pay range for this role is $245,000 - $307,000 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 Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

Salary : $245,000 - $307,000