Senior Manager, Global Data Generation

Summit Therapeutics•Palo Alto, CA

1d•$158,000 - $185,000

About The Position

Summit Therapeutics is seeking a Senior Manager, Global Data Generation to support the Global Non-Sponsored Research Program led by Medical Affairs. The program includes Investigator Sponsored Trials (ISTs), Cooperative Group studies, and real-world evidence studies. The role supports key aspects of the program and is responsible for activities related to study activation, tracking, and reporting. The Senior Manager works in a cross-functional environment and frequently interfaces with Summit’s Scientific Review Committee, field medical affairs, external collaboration partners, and investigators, including key opinion leaders. The ideal candidate is comfortable in a fast-paced environment and collaborates effectively with external stakeholders and internal teams.

Requirements

Bachelor’s or master’s degree in life sciences with relevant experience.
At least 3 years of relevant clinical trial management experience in a CRO, pharmaceutical or biotech company, or related role in the pharmaceutical or healthcare industry.
In-depth understanding of the healthcare and pharmaceutical landscape, clinical drug development phases and processes, and regulatory requirements.
Strong organizational skills, attention to detail, critical thinking, and problem-solving abilities.
Excellent communication and interpersonal abilities.
Ability to collaborate across diverse teams and manage multiple stakeholders.
Proficiency with the standard Microsoft Office suite, including Word, Excel, and PowerPoint.
Ability to self-motivate, multitask, work independently, and achieve success with little oversight or guidance.

Nice To Haves

Advanced degree, such as a PharmD or PhD.
Familiarity with software platforms for managing ISTs, such as iEnvision ISR, and fair market value analysis tools, such as IQVIA Grant Plan for Investigators.
Scientific and medical terminology acumen; oncology experience is strongly preferred.
Experience with electronic document management systems and document review tools.

Responsibilities

Manage operational aspects of studies, including protocol and consent review, document management, fair market value evaluations, contract execution, drug shipments, and ongoing oversight to ensure timelines and team goals are met.
Manage concept proposal intake, maintain the submission portal and review status, document decisions, and communicate with investigators and research coordinators.
Assist with agendas and prepare meeting materials and minutes for Scientific Review Committee meetings.
Obtain internal approval of study budgets, perform Fair Market Value analysis, and conduct budget negotiations when needed.
Work with Regional Medical Science Directors (RMSDs), Medical Science Liaisons (MSLs), principal investigators, and other external parties to maintain a central progress tracker for approved proposals and help ensure study timelines are met.
Support analyses, tracking, and reporting of study progress against investigator-committed timelines, data delivery, program impact, and other metrics.
Track milestones that trigger payment and work with Finance on budget reconciliation and forecasting future milestones.
Work with the study site and drug supply team to manage and forecast program drug supply.
Participate in cross-functional team meetings to provide program updates and address issues or concerns.
Collaborate with internal stakeholders, including Medical Affairs, Clinical Development, Regulatory, and Drug Supply.
Follow relevant processes, training, and SOPs to support consistency, efficiency, and compliance.
Contribute to ongoing process improvements.