Senior Manager, Medical Affairs

This position will be on-site in one of the following locations: San Francisco Bay Area / Dallas, TX / Miami, FL / Princeton, NJ

*Relocation support will be considered for this role

Overview of 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

Experience, Education and Specialized Knowledge and Skills:

• 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

The pay range for this role is $153,000 to $180,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

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.