Summit Therapeutics, Inc. · 4 hours ago
Director, Clinical Operations
Princeton, NJ
Full-time
Hybrid
Director/Executive
$190K/yr - $230K/yr
10+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing unmet medical needs. The Director will lead cross-functional study teams for clinical development programs, overseeing the execution of clinical trials and ensuring compliance with regulatory standards.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
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
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
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
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
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
Support clinical and non-clinical supplies planning for trial execution
Truth Seekers, who are detailed, rational, and humble problem solvers
Individuals Who Inspire Excellence in themselves and those around them
High-quality executors, who execute against goals and milestones with quality, precision, and speed
All other duties as assigned
Qualification
Required
BA/BS required in a scientific/medical field preferred
A minimum of 10+ years of experience in managing global clinical trials at all stages of development
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
Strong vendor management experience required
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
Experience with a submission-ready eTMF, regulatory inspections and/or inspection-readiness activities
Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations
Demonstrate strong leadership and matrix management skills, ability to multi-task in a dynamic and fast-paced environment
Strong interpersonal, negotiation, influencing, problem-solving skills
Excellent written and verbal skills required
Willing to travel domestically and internationally up to 20% of the time
Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
Strong computer and database skills
Attention to detail, accuracy and confidentiality
Clear and concise oral and written communication skills
Excellent organizational skills
Critical thinking, problem solving, ability to work independently
Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
Communicate effectively and articulate complex ideas in an easily understandable way
Prioritize conflicting demands
Work in a fast-paced, demanding and collaborative environment
Preferred
Experience in rare/orphan disease areas is preferred
Strong project management experience and skills is preferred
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
Company data provided by crunchbase