Overview of Role:
Summit Therapeutics is seeking a Senior Manager, Global Data Generation (Sr. Mgr.), to join our mission of developing Ivonescimab, a novel and unique immunotherapy with the potential to help patients suffering from life-threatening cancers. This position 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 Sr. Mgr. contributes to key aspects of the program and is responsible for activities associated with the activation, tracking, and reporting of study-related information. This role provides an opportunity to work in a cross-functional environment, interfaces 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.
Role and Responsibilities:
- 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, conduct 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 proposals to ensure study timelines are met
- Support ongoing analyses, tracking and reporting of study progress versus timelines committed by investigators, data delivery and program impact, and other related metrics
- Track achievement of milestones 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, training, and SOPs to ensure consistency, efficiency, and compliance.
- Continued process improvements to ensure consistency, efficiency, and compliance.
Experience, Education and Specialized Knowledge and Skills:
- Bachelor's or master's degree in life sciences with relevant experience; an advanced degree (e.g., PharmD, PhD) is preferred
- 3+ 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 Grant Plan 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