Director, Clinical Operations Study Start-Up

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.

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: The Director of Clinical Operations Study Start-Up will oversee the Study Start-Up portfolio managing Study Start-Up activities. This role takes direction from the Clinical Operations Leadership, will set the strategic direction for Study Start-Up planning and will provide oversight and leadership to drive the Study Start-Up activities. Furthermore, the Director, Site Contract and SSU will work collaboratively with all business partners to communicate decisions, issues, risks, and mitigations and will function as an SME to drive accelerated Start-Up timelines.

Responsibilities

: Provide strategic and operational leadership for end‑to‑end study start‑up activities across assigned clinical programs, ensuring timely, compliant, and high‑quality site activation. Leads multiple programs to ensure investigative sites are activated in accordance with the timelines set for each study. Accountable for development, execution, and ongoing optimization of study‑specific start‑up strategies, including country selection, regulatory and ethics submissions, site feasibility and selection, contract and budget execution, and site activation readiness.

Establish and maintain clear start‑up timelines, metrics, and dashboards; proactively identify risks to activation timelines and drive mitigation plans to achieve first site activation (FSI).

Requirements

Monitor vendor performance and participate in Vendor Governance as needed.

and communicates in advance to the internal team to plan and mitigate risk. Analyzes projects through the collection, tracking and trending metrics and KPI assessments and guides internal and external teams to achieve industry leading results for study activation.