Summit Therapeutics, Inc. · 1 day ago
Senior Director, Clinical Operations (TMF & CTMS)
Menlo Park, CA
Full-time
Hybrid
Director/Executive
$230K/yr - $250K/yr
12+ years expSummit Therapeutics, Inc. is a biopharmaceutical company focused on developing innovative therapies. They are seeking a Senior Director, Clinical Operations (TMF) to lead and optimize clinical trial operations and document management systems, ensuring high compliance standards and effective team leadership.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Develop, implement, and oversee the CTMS and TMF systems and related processes
Lead the oversite of TMF and CTMS vendors, contractors, and cross-functional teams
Provide leadership and development to existing TMF employees and lead by example by demonstrating our core values
Define, eexecute, and communicate the strategic vision for TMF and CTMS to maximize end user focus and engagement
Partner with key internal and external stakeholders to remediate risks and manage emerging issues
Develop proactive approaches to process improvements and enhancements of TMF and CTMS capabilities and standards
Provide business level leadership, foster best practices, and mentor and consult on TMF and CTMS across the Development and Operations organizations
Lead a team of TMF and CTMs colleagues and ensure their continuous development
Develop and maintain effective working relationships with stakeholder functions to achieve Clinical Operations goals
Keep current on changes in industry and regulatory standards for GCP requirements and advises on business impact for TMF and CTMS
Provide strategic leadership, insight, and guidance as an active member of the Clinical Operations Extended Leadership Team (XLT)
Ensure inspection ready TMF and CTMS and provide expert support for audits and inspections
Instill a culture of continuous improvement; acts as a change champion and effectively leads change
Other key assignments including ad hoc and stretch assignments in support of Clinical Operations and clinical trial execution
Travel on assignment (~25%)
All other duties as assigned
Qualification
Required
Bachelor's degree (e.g. BA, BS or equivalent) required
A minimum of 5+ years of experience in people management/leadership
Proven line and functional manager experience, able to effectively lead teams including regional (multi-country) and remote-based staff
Strong comprehensive and current regulatory knowledge, including ICH Good Clinical Practice, regulations and guidelines
Preferred
Preferably in life science; a clinical or advanced degree in a science, health related, or industry related discipline
Minimum of 12+ years of strong experience with a pharmaceutical company and/or CRO with increasing levels of responsibility in Clinical Operations in a global environment (including directing platform support teams and key clinical systems such as TMF, CTMS)
Experience in Phase III execution of clinical trials; Oncology trials
Previous regulatory inspection experience
Significant vendor oversight experience including contracts and budget management
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
2025-12-09
2025-12-05
Company data provided by crunchbase