Senior Director Clinical Operations, Study

Senior Director Clinical Operations, Study Start‑Up

Location: On-Site 4 days per week at our Menlo Park, CA, 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. 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 its clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:

• HARMONi:
  Phase 3 clinical study evaluating ivonescimab combined with chemotherapy versus placebo plus chemotherapy in patients with EGFR‑mutated, locally advanced or metastatic non‑squamous NSCLC previously treated with a 3rd generation EGFR TKI.
• HARMONi‑3:
  Phase 3 clinical study evaluating ivonescimab combined with chemotherapy versus pembrolizumab combined with chemotherapy in first‑line metastatic NSCLC patients.
• HARMONi‑7:
  Phase 3 clinical study evaluating ivonescimab monotherapy versus pembrolizumab monotherapy in first‑line metastatic NSCLC patients.

• HARMONi‑GI3:
  Phase 3 clinical study evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

We are seeking an experienced Senior Director, Study Start‑Up to lead global study start‑up activities across our oncology clinical development portfolio. This highly visible, hands‑on leadership role is responsible for enabling rapid first‑patient‑in (FPI) timelines while ensuring quality, compliance, and inspection readiness. The ideal candidate brings deep expertise in oncology study start‑up, thrives in a lean biotech environment, and can balance strategic leadership with operational execution across Phase II–III trials.

As the department scales, this leader will evolve the function into a Center of Excellence for Site Activation, utilizing predictive analytics and standardized workflows to drive portfolio‑wide efficiency.

• Lead and oversee global oncology study start‑up activities from site selection through site activation.
• Drive timely site activations across regions, regulatory readiness, contracts, budgets, and essential core documents.
• Collaborate with legal, finance, CRO and clinical teams to ensure site agreements comply with country regulatory and company standards.
• Partner closely with legal counsel to ensure appropriate indemnification, liability, and confidentiality provisions are included in contracts; oversee negotiation of clinical trial insurance certificates and country‑specific mandates.
• Manage and develop a team of direct reports, providing mentorship, performance management, and career development; extend mentorship to non‑direct reports within the broader Clinical Operations department to harmonize start‑up best practices.
• Build, optimize, and scale study start‑up processes, SOPs, and playbooks suitable for a growing biotech; lead formal process improvement initiatives to reduce cycle times.
• Drive standardization of core study documents, including global Master ICFs, Investigator Packages, and essential document checklists to ensure consistency and speed.
• Partner with Business Operations and IT to identify and implement technology solutions (e.g., SSU tracking modules, eTMF automation) to replace manual processes and improve data transparency.
• Collaborate closely with Clinical Operations, Clinical Development, Quality, Legal, and Finance.
• Present the budget to the Chief Accounting Officer and Head of Clinical Operations for approval, ensuring full knowledge of all details.
• Partner with Finance to provide study‑wide site payment estimates and…