Senior Manager, Externally Sponsored Research

The role

This person will support the Global Non-Sponsored Research Program by managing operational aspects of studies. They will handle activities related to the activation, tracking, and reporting of study-related information.

What you will do

• Manage all operational aspects of studies including protocol review, document management, and contract execution
• Manage the concept proposal intake process and maintain the submission portal
• Assist with agenda and prepare meeting materials for Scientific Review Committee meetings
• Obtain internal approval of study budget and perform Fair Market Value analysis
• Work with external parties to maintain a central progress tracker for approved proposals
• Support ongoing analyses and tracking of study progress and data delivery
• Track achievement of milestones that trigger payment and work with Finance on budget reconciliation
• Work with study site and drug supply team to manage and forecast drug supply
• Participate in cross-functional team meetings
• Adhere to all relevant processes, training, and SOPs

Required qualifications

• Bachelor’s or master’s degree in life sciences with relevant experience
• 3+ years of relevant experience working in clinical trial management in CRO, pharmaceuticals/biotech, or related roles
• 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)
• 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

Nice to have

• Advanced degree (e.g., PharmD, PhD)
• Experience in Oncology
• Experience with electronic document management systems and document review tools

Benefits

• bonus
• stock
• benefits
• other applicable variable compensation

About the company

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.