Summit Therapeutics, Inc. · 2 weeks ago
Senior Director Clinical Operations, Study Start-Up
Menlo Park, CA
Full-time
Onsite
Director/Executive
$225K/yr - $280K/yr
12+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. They are seeking a Senior Director to lead global study start-up activities across their oncology clinical development portfolio, ensuring rapid timelines and quality compliance.
BiotechnologyHealth CareMedical DeviceTherapeutics
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
Qualification
Required
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
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
Preferred
Experience in GrantPlan
Benefits
Bonus
Stock
Benefits
Other applicable variable compensation
Company
Summit Therapeutics, Inc.
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs.
201-500 employees
H1B Sponsorship
Summit Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.79BKey Investors
CARB-XEurofarmaBiomedical Advanced Research and Development Authority (BARDA)
2025-10-21Post Ipo Equity· $500M
2024-09-11Post Ipo Equity· $235M
2024-06-03Post Ipo Equity· $200M
Leadership Team
Manmeet Soni
Chief Operating Officer and Board Member
Recent News
The Motley Fool
2026-01-13
Pharmaceutical Technology
2026-01-13
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