Senior Manager Medical Affairs
Senior Manager Medical Affairs
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$ 153000 - 180000
1 Vacancy
Job Description
This position will be onsite 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 lifethreatening cancers. This position will focus on supporting the Global NonSponsored 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 studyrelated information. This role provides an outstanding opportunity to work in a crossfunctional environment interfaces frequently with Summits Scientific Review Committee field medical affairs external collaboration partners and investigators including key opinion leaders.
The ideal candidate will thrive in a fastpaced environment and be adept at collaborating with external stakeholders and crossfunctional 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 prestudy activation activities including coordinating protocol/ICF and budget review collect necessary regulatory documents and manage contract
- 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 crossfunctional team meetings to provide updates on the program and address any issues or concerns
- Collaborate crossfunctionally 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:
- Bachelors 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
- Indepth 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 problemsolving 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
- Selfmotivated ability to multitask and work independently and achieve success with little oversight or guidance
- Able to travel as necessary up to 1020 of the time
The pay range for this role is $153000 to $180000 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 Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.
Required Experience:
Senior Manager
Employment Type
Full-Time
