Associate Director, Data Generation jobs in United States
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Summit Therapeutics, Inc. · 22 hours ago

Associate Director, Data Generation

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing unmet medical needs. The Associate Director, Global Data Generation will drive the strategy and execution of data generation initiatives to support development and commercialization, collaborating cross-functionally to ensure alignment with clinical and scientific objectives.

BiotechnologyHealth CareMedical DeviceTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Independently oversee all operational aspects of non-sponsored research studies, delivering comprehensive end-to-end management. Responsibilities include planning discussions, protocol development, site coordination, document management, contract execution, fair market value evaluations, drug shipments, and oversight of project budgets and execution to ensure timelines and team goals are met
Responsible for identifying key data gaps and developing strategies to address them through innovative research approaches. This includes proactively engaging with both internal and external stakeholders to assess emerging scientific trends and opportunities that may impact the Company’s research program
This role requires a forward-thinking mindset to anticipate future evidence needs and to ensure that data generation activities are both comprehensive and strategically aligned with clinical, regulatory and commercial objectives
Develop metrics and dashboards to monitor the progress and impact of data generation initiatives, providing regular updates to leadership and key stakeholders
Oversee the development and organization of the content, summaries and outcomes from the IST Scientific Review Committee meetings as a member of the cross-functional committee
Liaise with study sites and the CMC/IMP team to manage and forecast drug supply requirements for the program
Work with external vendor to oversee the development and optimization of the IST platform system
Work in conjunction with the finance team to conduct Fair Market Value evaluations for approved non-sponsored research protocols, track achievement of milestones that trigger payment, and perform budget reconciliation as well as forecast future milestone
Partner with cross-function teams, including clinical, regulatory, PV/safety, biostatistics, and CMC to ensure effective management of the IST program
Manage all Non-Sponsored Research trial contracts working closely with legal
Remain abreast of new operations standards, platforms and practices and champion best practice adoption by Summit GMA
Foster and maintain strong relationships with external stakeholders, including key opinion leaders (KOLs), investigators, and global cooperative research groups, to facilitate successful collaborations and ensure timely and effective execution of research initiatives
Provide guidance and support for the review and approval of study concepts and protocols, ensuring compliance with regulatory and ethical standards throughout all phases of project development
Functional expertise to initiate, author, or contribute to SOP development, implementation, and training, participate in process improvement exercises to drive operational excellence
All other duties as assigned

Qualification

Oncology researchClinical trial managementIST management softwareData analysisProject managementMS Office proficiencyInterpersonal skillsCritical thinkingAttention to detail

Required

Minimum of 7+ years of experience in a relevant role within the pharmaceutical industry required
Experience working in clinical trial management, research management, and/or Medical Affairs research programs; Familiarly with clinical research terminology required
Experience with IST management software platforms (e.g. iEnvision ISR platform) and tools and fair market value analysis (e.g. IQVIA GrantPlan for Investigators)
Experience producing and analyzing metrics/reports
Strong clinical/scientific acumen required including the ability to interpret, analyze, organize, and communicate scientific data
Strong interpersonal and communication skills with the ability to work effectively in a cross-functional, matrixed organization
Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools
Strong computer and database skills
High attention to detail, strong analytical, and organizational skills
Critical thinking, problem solving, and ability to work independently
Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
Work in a fast-paced, demanding, and collaborative environment

Preferred

Advanced degree (PhD or equivalent) in life sciences or related field highly preferred, candidates with a master's degree in life sciences and extensive relevant experience will be considered
A strong focus in oncology preferred
Experience working with KOLs, academic institutions, and community physicians is a plus
Non-Sponsored Research/Investigator Sponsored Trial (IST) management experience preferred

Benefits

Bonus
Stock
Benefits
Other applicable 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 Board Member
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Company data provided by crunchbase