Senior Director, Clinical Operations

Role Summary

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. This role should demonstrate strong matrix management skills, confidence in working independently, and have proven ability to champion a team to deliver on key study milestones. In addition, the Senior Director will be responsible for assisting in study design, planning, and execution of clinical trials while operating within budget and per established timelines, regulatory and quality standards.

Responsibilities

• Study Execution: Oversee and manage the execution of one or more phase 1-3 clinical trials. Management of all clinical operations support vendors contracted for the assigned study(ies), including budgets and timelines oversight, performance management, risk management, and issue resolution.
• Study Planning and Management: Establish and coordinate all ongoing study management activities, including leading the cross-functional study team development of an overall study execution plan to deliver key study deliverables. Daily activities may include updating/reviewing study documents (protocols, informed consent forms, clinical study reports, site facing material, etc.), monitoring study status across internal functions and external vendors, anticipating and mitigating risks within the timeline, quality, and study budget.
• Study Team Meetings: Lead team meetings, as assigned, both internally and with multiple vendors. Attend Project Team and/or Executive Team Meetings, as required.
• Study Site Management: Cultivate and maintain strong relationships with investigators and trial site administrators; Organize investigator meetings as needed; contributes to the development of abstracts, presentations, and manuscripts for studies.
• Clinical Trial Budgeting: Maintain oversight of clinical operations budget, including regular forecasting and internal reporting to management and finance; review vendor invoices against the scope of work and work completed to date; identify and communicate discrepancies.
• Quality Control: Support the development of quality control processes and study plans to ensure that clinical activities are compliant with Good Clinical Practice and regulatory guidelines. Ensure execution of trials according to the study protocol and procedures, SOPs, ICH/GCP, FDA, EMEA, NICE, and other relevant policies and regulations.
• Supply Chain Management: Support clinical and non-clinical supplies planning for trial execution.
• All other duties as assigned

Qualifications

• BA/BS required; in a scientific/medical field preferred
• At least 15+ years of experience in managing global clinical trials at all stages of development
• Strong vendor management experience required
• Experience in oncology trial management is strongly preferred
• Demonstrated ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking and reporting activities
• Demonstrated successful management and oversight of CROs and other service providers
• Deep understanding of clinical trial design, protocol development/ review, and running the clinical trial meetings
• Significant experience with cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activities
• Experience organizing and/or participating in specific study-related advisory committees (e.g., steering committee, data monitoring committees, adjudication committees)
• Experience in the management and maintenance of EDC, CTMS, IxRS, ePRO, etc.
• Experience in Quality Assurance, SOP and Study Plans writing, CAPA preparation, and closure
• Strong attention to detail with the ability to lead and function as rational and humble problem solver
• Leadership experience with the ability to inspire excellence in themselves and those around them
• High-quality executor; ability to execute against goals and milestones with quality, precision, and speed

Skills

• Cross-functional leadership
• Vendor management
• Budgeting and forecasting
• Regulatory compliance (GCP/ICH/FDA/EMEA/NICE)
• Clinical study design and execution
• Trial planning, monitoring, and reporting
• EDC, CTMS, IxRS, ePRO systems

Education

• BA/BS required; science/medical field preferred

Additional Requirements

• Location: On-site in Menlo Park, CA or Miami, FL