Senior Manager, Global Data Generation jobs in United States
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Summit Therapeutics, Inc. · 6 days ago

Senior Manager, Global Data Generation

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. The Senior Manager, Global Data Generation will support the Global Non-Sponsored Research Program and manage operational aspects of studies, ensuring timelines and team goals are met.

BiotechnologyHealth CareMedical DeviceTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Independently manage all operational aspects of studies, including protocol/consent review, document management, fair market value evaluations, contract execution, drug shipments, and maintain ongoing oversight of project to ensure timelines and team goals are met
Manage the concept proposal intake process, maintain the submission portal and review status, document decisions and communicate with investigators and research coordinators
Assist with agenda and prepare meeting materials/minutes for Scientific Review Committee meetings
Responsible for obtaining internal approval of associated study budget, perform Fair Market Value analysis, conducts budget negotiations when needed
Work closely with Regional Medical Science Directors (RMSDs)/Medical Science Liaisons (MSLs), principal investigators, and other external parties to maintain central progress tracker for all approved proposal to ensure study timelines are met
Support ongoing analyses, tracking and reporting of study progress versus timelines committed by investigator, data delivery and program impact, and other related metrics
Track achievement of milestone that trigger payment, and work with Finance to perform budget reconciliation as well as forecast future milestone
Work with study site/drug supply team to manage and forecast drug supply for the program
Participate in cross-functional team meetings to provide updates on the program and address any issues or concerns
Collaborate cross-functionally with internal stakeholders, including medical affairs, clinical development, regulatory, drug supply, etc
Adheres to all relevant processes, trainings, and SOPs to ensure consistency, efficiency, and compliance. Continued process improvements to ensure consistency, efficiency, and compliance

Qualification

Clinical trial managementOncology experienceRegulatory requirements knowledgeIEnvision ISR platformIQVIA GrantPlanMS Office proficiencyCommunication skillsOrganizational skillsCritical thinkingInterpersonal skillsSelf-motivated

Required

Bachelor's or master's degree in the life sciences with extensive relevant experience; an advanced degree (e.g., PharmD, PhD) is preferred
5+ years of relevant experience working in clinical trial management in CRO, pharmaceuticals/biotech, or related roles within the pharmaceutical or healthcare industry
In-depth understanding of the healthcare and pharmaceutical landscape and phases of clinical drug development and processes, including regulatory requirements
Familiarity with software platforms for managing ISTs (e.g. iEnvision ISR platform) and tools and fair market value analysis (e.g. IQVIA GrantPlan for Investigators)
Scientific and medical terminology acumen, experience in Oncology strongly preferred
Strong organizational skills, attention to detail, critical thinking and high problem-solving abilities
Excellent communication and interpersonal abilities
Ability to work collaboratively across diverse teams and manage multiple stakeholders
Proficient user of the standard MS Office suite (e.g., Word, Excel, PowerPoint); experience with electronic document management systems and document review tools is desirable
Self-motivated, ability to multi-task and work independently and achieve success with little oversight or guidance
Able to travel as necessary up to 10-20% of the time

Preferred

An advanced degree (e.g., PharmD, PhD)
Experience in Oncology strongly preferred
Experience with electronic document management systems and document review tools is desirable

Benefits

Bonus
Stock
Benefits
Variable compensation

Company

Summit Therapeutics, Inc.

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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.

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 Company
Total Funding
$1.79B
Key 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

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Manmeet Soni
Chief Operating Officer and Chief Financial Officer
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Company data provided by crunchbase