Sr Manager, Externally Research

About Summit Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit believes in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people.

Our employees are the heart and soul of our culture, invaluable in shaping our journey toward excellence. Summit has multiple global Phase 3 clinical studies in oncology, including non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland.

The Senior Manager, Global Data Generation, will focus on supporting the Global Non-Sponsored Research Program led by Medical Affairs, including Investigator Sponsored Trials (ISTs), Cooperative Group studies, as well as real-world evidence studies. The Senior Manager contributes to key aspects of the program and is responsible for activities associated with activation, tracking, and reporting of study-related information. This role provides an opportunity to work in a cross-functional environment, interfacing frequently with Summit’s Scientific Review Committee, field medical affairs, external collaboration partners and investigators, including key opinion leaders.

The ideal candidate will thrive in a fast-paced environment and be adept at collaborating with external stakeholders and cross-functional internal teams.

• 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 milestones
• 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.

• Bachelor’s or master’s degree in the life sciences with extensive relevant experience; an advanced degree (e.g., Pharm
  
  D, 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…