Summit Therapeutics, Inc.
Director, Clinical Operations
Summit Therapeutics, Inc., Menlo Park, California, United States, 94029
Director Clinical Operations
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving the quality of life and extending survival for patients with serious unmet medical needs.
The Director will serve as the cross‑functional study team lead for our clinical development program, responsible for delivering all clinical trial operational activities across multiple studies. This role requires strong matrix management skills, the ability to work independently, and the proven ability to champion a team to achieve key study milestones while operating within budget, timelines, regulatory, and quality standards.
Responsibilities
Oversee and manage the execution of one or more Phase 1‑3 clinical trials, including managing all clinical operations support vendors, budgets, timelines, performance, risk, and issue resolution.
Establish and coordinate all ongoing study management activities, leading the cross‑functional team in developing overall study execution plans to deliver key deliverables.
Lead team meetings internally and with vendors; attend project and executive team meetings as required.
Maintain relationships with investigators and site administrators, organize investigator meetings, and contribute to abstracts, presentations, and manuscripts.
Oversee clinical operations budgeting, forecast, and reporting to management and finance; review vendor invoices and communicate discrepancies.
Support development of quality control processes and study plans to ensure compliance with Good Clinical Practice, ICH/GCP, FDA, EMEA, NICE, and other relevant regulations.
Support clinical and non‑clinical supply planning for trial execution.
Execute all other duties as assigned.
Qualifications
BA/BS in a scientific or medical field preferred.
10+ years of experience managing global clinical trials at all development stages.
Experience in rare/orphan disease areas is preferred.
Demonstrated success in managing and delivering trials from start‑up through close‑out, including financial tracking and reporting.
Strong CRO and service provider vendor management experience.
Deep understanding of clinical trial design, protocol development, and review.
Experience with cross‑functional leadership, data review, protocol deviation review, database lock, CSR development, and study reporting.
Experience organizing or participating in advisory committees such as steering or data monitoring committees.
Experience with EDC, CTMS, IxRS, ePRO, and other study systems.
Knowledge of quality assurance, SOP writing, CAPA, eTMF, and inspection readiness activities.
Strong knowledge of GCP (ICH GCP E6 R2) and regulatory frameworks.
Strong project management, interpersonal, negotiation, influencing, and problem‑solving skills.
Demonstrated leadership and matrix management skills in a dynamic, fast‑paced environment.
Compensation Pay range: $186,000 – $233,000 annually. Compensation packages are based on skill set, depth of experience, certifications, and work location. Total compensation may include bonus, stock, benefits, and other variable components.
Seniority Level Director
Employment Type Full‑time
Job Function Strategy/Planning and Information Technology
Location South San Francisco, CA
#J-18808-Ljbffr
The Director will serve as the cross‑functional study team lead for our clinical development program, responsible for delivering all clinical trial operational activities across multiple studies. This role requires strong matrix management skills, the ability to work independently, and the proven ability to champion a team to achieve key study milestones while operating within budget, timelines, regulatory, and quality standards.
Responsibilities
Oversee and manage the execution of one or more Phase 1‑3 clinical trials, including managing all clinical operations support vendors, budgets, timelines, performance, risk, and issue resolution.
Establish and coordinate all ongoing study management activities, leading the cross‑functional team in developing overall study execution plans to deliver key deliverables.
Lead team meetings internally and with vendors; attend project and executive team meetings as required.
Maintain relationships with investigators and site administrators, organize investigator meetings, and contribute to abstracts, presentations, and manuscripts.
Oversee clinical operations budgeting, forecast, and reporting to management and finance; review vendor invoices and communicate discrepancies.
Support development of quality control processes and study plans to ensure compliance with Good Clinical Practice, ICH/GCP, FDA, EMEA, NICE, and other relevant regulations.
Support clinical and non‑clinical supply planning for trial execution.
Execute all other duties as assigned.
Qualifications
BA/BS in a scientific or medical field preferred.
10+ years of experience managing global clinical trials at all development stages.
Experience in rare/orphan disease areas is preferred.
Demonstrated success in managing and delivering trials from start‑up through close‑out, including financial tracking and reporting.
Strong CRO and service provider vendor management experience.
Deep understanding of clinical trial design, protocol development, and review.
Experience with cross‑functional leadership, data review, protocol deviation review, database lock, CSR development, and study reporting.
Experience organizing or participating in advisory committees such as steering or data monitoring committees.
Experience with EDC, CTMS, IxRS, ePRO, and other study systems.
Knowledge of quality assurance, SOP writing, CAPA, eTMF, and inspection readiness activities.
Strong knowledge of GCP (ICH GCP E6 R2) and regulatory frameworks.
Strong project management, interpersonal, negotiation, influencing, and problem‑solving skills.
Demonstrated leadership and matrix management skills in a dynamic, fast‑paced environment.
Compensation Pay range: $186,000 – $233,000 annually. Compensation packages are based on skill set, depth of experience, certifications, and work location. Total compensation may include bonus, stock, benefits, and other variable components.
Seniority Level Director
Employment Type Full‑time
Job Function Strategy/Planning and Information Technology
Location South San Francisco, CA
#J-18808-Ljbffr