Senior Director Clinical Operations, Study Start-Up

Summit Therapeutics Plc•Menlo Park, CA

7d•$225,000 - $280,000•Onsite

About The Position

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.

Requirements

Bachelor's degree in Life Sciences, Business Administration or related field required
At least 12+ years of experience in managing global clinical trials
Proven track record of successfully managing direct reports and leading cross-functional teams through influence in a matrixed environment.
Demonstrated experience in process improvement and the application of technology to streamline clinical operations.
Deep knowledge of ICF development, clinical trial insurance requirements, protocol amendment process, and global regulatory document standards.
Strong negotiation and vendor management experience required
Experience in oncology trial management
Data-driven leader with expertise in start-up metrics and forecasting
Demonstrated successful management and oversight of CROs and other service providers
Ability to operate strategically while remaining hands-on and execution-focused
Ensure compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and internal standard operating procedures (SOPs) throughout the study start-up phase
Comfortable working in fast-paced, resource-lean biotech environments
Experience in GrantPlan
Excellent communication and cross-functional leadership skills
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

Responsibilities

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 global Master Informed Consent Forms (ICF), Investigator Packages, and essential document checklists to ensure consistency and speed.
Partner with Business Operations and IT to identify and implement technology solutions (e.g., SSU tracking modules, eTMF automation) to replace manual processes and improve data transparency.
Partner closely with Clinical Operations, Clinical Development, Quality, Legal, and Finance
Confidently present the budget to the Chief Accounting Officer and Head of Clinical Operations for approval, ensuring full knowledgeable of all details
Partner with Finance team to provide study-wide site payment estimates and forecasts
Provide regular updates to management on progress and key performance indicators related to trial agreements
Establish and track start-up KPIs and metrics to improve predictability and cycle times
Provide oversight and governance of CROs, FSP Providers and start-up vendors, including performance management and issue escalation