What are the responsibilities and job description for the Senior Manager, Medical Affairs position at Summit Therapeutics, Inc.?
This position will be on-site in one of the following locations: San Francisco Bay Area / Dallas, TX / Miami, FL / Princeton, NJ
Summit Therapeutics is seeking a Senior Manager, Medical Affairs, 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) and Cooperative/Consortium/Network studies. The Senior Manager 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 outstanding 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
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
- Relocation support will be considered for this role
Summit Therapeutics is seeking a Senior Manager, Medical Affairs, 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) and Cooperative/Consortium/Network studies. The Senior Manager 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 outstanding 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 the research proposal intake process, maintain the submission portal and review status, document decisions and communicate with investigators and research coordinator
- Assist with agenda and prepare meeting materials/minutes for Scientific Review Committee meetings
- Project manage pre-study activation activities including coordinating protocol/ICF and budget review, collect necessary regulatory documents, and manage contract execution
- 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
- Responsible for ongoing analyses, tracking and reporting of study progress versus timelines committed by investigator, data delivery and program impact, and other related metrics in support of program activities
- 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.
- All other duties as assigned
- Bachelor’s degree in the life sciences or in a related field; an advanced degree (e.g., PharmD, PhD) is preferred
- 8 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
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
Salary : $153,000 - $180,000