Summit Therapeutics, Inc.
Senior Director, Clinical Operations
Summit Therapeutics, Inc., Menlo Park, California, United States, 94029
Senior Director, Clinical Operations
Summit Therapeutics, Inc. is seeking a Senior Director of Clinical Operations to lead the development of our oncology pipeline, with a primary office location in Menlo Park, CA or Miami, FL.
Location:
Menlo Park, CA or Miami, FL
Overview of Role The Senior Director of Clinical Operations will serve as a cross‑functional study team lead for the clinical development program, responsible for delivering all clinical trial operational activities across multiple studies for Summit Therapeutics. The role requires strong matrix management skills, independence, and proven ability to champion a team to deliver on key study milestones while operating within budget, regulatory and quality standards.
Responsibilities
Study Execution : Oversee and manage the execution of one or more phase 1–3 clinical trials. Manage all clinical operations support vendors, budgets, timelines, risk and issue resolution.
Study Planning and Management : Establish and coordinate all study management activities, lead the cross‑functional team’s overall study execution plan, update and review study documents, monitor study status across functions and vendors, and mitigate risks within timeline, quality and budget.
Study Team Meetings : Lead team meetings, attend Project or Executive Team Meetings, and coordinate with vendors as required.
Study Site Management : Cultivate relationships with investigators and site administrators, organize investigator meetings, and contribute to abstracts, presentations, and manuscripts.
Clinical Trial Budgeting : Maintain oversight of clinical operations budget, provide forecasting and reporting to management and finance, review vendor invoices, and communicate discrepancies.
Quality Control : Support development of quality control processes and study plans to ensure GCP and regulatory compliance.
Supply Chain Management : Support planning of clinical and non‑clinical supplies for trial execution.
All other duties as assigned.
Experience, Education and Specialized Knowledge
BA/BS required (scientific/medical field preferred).
At least 15+ years managing global clinical trials at all stages of development.
Strong preference for oncology trial management experience.
Successful delivery of clinical trials from start‑up through close‑out, including financial tracking and reporting.
Experience managing CROs and other service providers.
Deep understanding of trial design, protocol development/review, and cross‑functional leadership.
Experience with data review, protocol deviation review, database lock, CSR development, and study reporting.
Experience with advisory committees (e.g., steering, data monitoring, adjudication).
Experience managing EDC, CTMS, IxRS, ePRO systems.
Experience in QA, SOP writing, CAPA preparation, and closure.
Strong attention to detail, problem‑solving, and leadership ability to inspire excellence.
High‑quality executor, capable of achieving goals and milestones with precision and speed.
Pay Range:
$240,000 – $285,000 annually, with additional bonus, stock, benefits and other variable compensation.
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Location:
Menlo Park, CA or Miami, FL
Overview of Role The Senior Director of Clinical Operations will serve as a cross‑functional study team lead for the clinical development program, responsible for delivering all clinical trial operational activities across multiple studies for Summit Therapeutics. The role requires strong matrix management skills, independence, and proven ability to champion a team to deliver on key study milestones while operating within budget, regulatory and quality standards.
Responsibilities
Study Execution : Oversee and manage the execution of one or more phase 1–3 clinical trials. Manage all clinical operations support vendors, budgets, timelines, risk and issue resolution.
Study Planning and Management : Establish and coordinate all study management activities, lead the cross‑functional team’s overall study execution plan, update and review study documents, monitor study status across functions and vendors, and mitigate risks within timeline, quality and budget.
Study Team Meetings : Lead team meetings, attend Project or Executive Team Meetings, and coordinate with vendors as required.
Study Site Management : Cultivate relationships with investigators and site administrators, organize investigator meetings, and contribute to abstracts, presentations, and manuscripts.
Clinical Trial Budgeting : Maintain oversight of clinical operations budget, provide forecasting and reporting to management and finance, review vendor invoices, and communicate discrepancies.
Quality Control : Support development of quality control processes and study plans to ensure GCP and regulatory compliance.
Supply Chain Management : Support planning of clinical and non‑clinical supplies for trial execution.
All other duties as assigned.
Experience, Education and Specialized Knowledge
BA/BS required (scientific/medical field preferred).
At least 15+ years managing global clinical trials at all stages of development.
Strong preference for oncology trial management experience.
Successful delivery of clinical trials from start‑up through close‑out, including financial tracking and reporting.
Experience managing CROs and other service providers.
Deep understanding of trial design, protocol development/review, and cross‑functional leadership.
Experience with data review, protocol deviation review, database lock, CSR development, and study reporting.
Experience with advisory committees (e.g., steering, data monitoring, adjudication).
Experience managing EDC, CTMS, IxRS, ePRO systems.
Experience in QA, SOP writing, CAPA preparation, and closure.
Strong attention to detail, problem‑solving, and leadership ability to inspire excellence.
High‑quality executor, capable of achieving goals and milestones with precision and speed.
Pay Range:
$240,000 – $285,000 annually, with additional bonus, stock, benefits and other variable compensation.
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