Summit Therapeutics, Inc.

Senior Manager, Global Data Generation

Summit Therapeutics, Inc.

full-time

Posted on:

Location Type: Office

Location: Palo Alto • California • Florida • United States

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Salary

💰 $174,000 - $204,500 per year

Job Level

Senior

About the role

  • Independently 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, 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
  • Support ongoing analyses, tracking and reporting of study progress versus timelines committed by investigator, data delivery and program impact, and other related metrics
  • 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.

Requirements

  • Bachelor's or master's degree in the life sciences with extensive relevant experience; an advanced degree (e.g., PharmD, PhD) is preferred
  • 5+ 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.
Benefits
  • 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.
  • The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trial managementbudget negotiationFair Market Value analysisdata trackingproject managementregulatory requirementsOncology experiencecritical thinkingproblem-solving
Soft Skills
organizational skillsattention to detailcommunication abilitiesinterpersonal abilitiescollaborative workmulti-taskingself-motivation
Certifications
Bachelor's degree in life sciencesMaster's degree in life sciencesPharmDPhD