Senior Director Clinical Operations, Study

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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 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.

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.

We are seeking an experienced Senior Director, Study Start-Up to lead global study start-up activities across our oncology clinical development portfolio. This is a highly visible, hands-on leadership role 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 be responsible for evolving 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 the complex negotiation of clinical trial insurance certificates and country-specific mandates.
• Manage and develop a team of direct reports, providing active 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 from site selection to activation.
• Drive the standardization of core study documents, including…