Summit Therapeutics, Inc. · 1 day ago
Therapeutic Area Head, Clinical Development
United States
Full-time
Remote
Director/Executive
$344K/yr - $430K/yr
10+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing unmet medical needs. The Therapeutic Area Head, Clinical Development will be responsible for developing and executing clinical trial programs in oncology, providing clinical expertise, and leading cross-functional teams to achieve operational excellence.
BiotechnologyHealth CareMedical DeviceTherapeutics
Hiring Manager
Lindsey Sheppard
Responsibilities
Significant oncology experience: the role will require expertise in the treatment and management of oncology disease such that knowledge can be applied to the strategy and clinical development of Summit medicines to benefit patients
Established network and relationships with oncology experts, investigators and opinion leaders
Work cross functionally with Medical Affairs, Regulatory, Commercial and other functions to develop the overall product strategy in multiple indications
Work cross functionally with Clinical Operations, Biometrics, Pharmacovigilance, and other functions to successfully complete clinical development programs leading to BLA approvals
Lead teams to execute on clinical development goals (clinical trial execution, clinical development strategy, medical affairs planning)
Manage direct reports or cross functional team members as needed based on team needs
Contribute to the communication strategy of Summit products via publications, manuscripts, abstracts, posters and scientific presentations
Make vital contributions and leading 1-2 pivotal programs in clinical development program
Direct human clinical trials, phases 1-3, for lead candidate in development, helping to ensure all clinical development milestones are met including enrollment goals
Participate in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals
Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and government, regulatory, or partner agencies
Present to various external stakeholders - regulators, governing and harmonization bodies, principal investigators, scientific conference attendees, advisors and opinion leaders
Maintain knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review
Plan, reviewing and editing Clinical Study Reports
Plan, reviewing and editing publications from the program
Provide input on the design of clinical studies supporting clinical strategy
All other duties as assigned
Qualification
Required
This position will be located on-site in Menlo Park, CA / Princeton, NJ / or Miami, FL
Significant oncology experience: the role will require expertise in the treatment and management of oncology disease such that knowledge can be applied to the strategy and clinical development of Summit medicines to benefit patients
Established network and relationships with oncology experts, investigators and opinion leaders
Work cross functionally with Medical Affairs, Regulatory, Commercial and other functions to develop the overall product strategy in multiple indications
Work cross functionally with Clinical Operations, Biometrics, Pharmacovigilance, and other functions to successfully complete clinical development programs leading to BLA approvals
Lead teams to execute on clinical development goals (clinical trial execution, clinical development strategy, medical affairs planning)
Manage direct reports or cross functional team members as needed based on team needs
Contribute to the communication strategy of Summit products via publications, manuscripts, abstracts, posters and scientific presentations
Make vital contributions and leading 1-2 pivotal programs in clinical development program
Direct human clinical trials, phases 1-3, for lead candidate in development, helping to ensure all clinical development milestones are met including enrollment goals
Participate in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals
Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and government, regulatory, or partner agencies
Present to various external stakeholders - regulators, governing and harmonization bodies, principal investigators, scientific conference attendees, advisors and opinion leaders
Maintain knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review
Plan, reviewing and editing Clinical Study Reports
Plan, reviewing and editing publications from the program
Provide input on the design of clinical studies supporting clinical strategy
Board certified or eligible MD with hematology/oncology product development and experience across stages of clinical development
10+ years' experience in pharmaceutical industry or biotech R&D environment
Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMEA
Self-starter who will move forward with key initiatives without being prompted, able to perform a myriad of tasks needed to support the clinical development program, possesses a highly entrepreneurial and growth mindset, works collaboratively with cross-functional teams, loves a good mission
Ability to lead a dynamic team and work in a fast-paced, hands-on and changing environment
Clear and provable evidence of effective leadership skills
Preferred
Experience in academic or research environment involving the collection and analysis of human data in the area of hematology/oncology
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