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Roivant Sciences // biomedical research
 
Roivant Sciences, 320 West 37th Street, New York City 10018, United States    Posted: Saturday, November 16, 2019
 
   
 
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JOB DETAILS
 

Aruvant Sciences is focused on developing & commercializing gene therapies for hematological diseases utilizing reduced-intensity conditioning.

Aruvant is seeking a VP of Program Management & Clinical Operations. In this role, you will be responsible for managing & overseeing operations & program management across the Aruvant development program. As the program management lead, you will play a critical role on the team, soliciting input from functional leadership & combining with your own development experience to formulate strategy & timelines, execute clinical studies & complete product registration. As the clinical operations lead, you will own study launch, execution, & close. You will be expected to determine resourcing needs for your function, & may be asked to provide input into due diligence evaluations.

Responsibilities:

  • Integrate inputs across development functions (clinical, manufacturing, regulatory) to ensure a comprehensive, integrated development strategy
  • Translate proposed development strategies into operational plans, including timelines, budgets, & resource requirements, & continually track progress against those plans
  • Highlight key milestones & risks to CMO & team members as needed
  • Ensure consistency & coordination across functions, including aligning timelines & connecting elements of the development plan to one another
  • Ensure that high operational standards are maintained across clinical program & drive operational excellence activities, including program & trial metrics, communication platforms, & process improvement initiatives
  • Identify recruitment goals, review & approve monitoring reports, manage budgets, & interface with CMC contact for study supplies

Requirements:

  • Graduate degree preferred
  • 10+ years experience managing cross-functional drug development teams or managing clinical operations for multiple clinical trials
  • Cell/gene therapy & hematology experience preferred
  • Experience working in situations with deep CMC / clinical interface preferred
  • Proven track record of project and/or operational support for successful IND, CTA, NDA, and/or BLA regulatory submissions
  • Consistently able to produce quick, thorough, & accurate work
  • Intellectual agility - able to pivot based on shifting priorities & balance multiple projects seamlessly in a fast-paced environment
  • Natural collaborator who enjoys working on a cross-functional team
  • Demonstrated leadership, communication, organization, & critical thinking/problem-solving skills
  • Understanding of Good Clinical Practice (GCP) & ethical study conduct
  • Understanding of clinical research process from program planning to regulatory submission
  • Excellent written & verbal communication skills & interpersonal skills. Must be able to interact effectively to people at all levels of the organization.
  • General understanding of good clinical trial design, conduct & reporting
  • Familiarity with strategy for efficient study enrollment
  • Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
  • Proven track record of project and/or operational support for successful BLA regulatory submissions

Qualifications/Critical characteristics include:

  • Entrepreneurial nature, self-driven, & task-oriented
  • Consistently able to produce quick, thorough, & accurate work
  • Natural collaborator who enjoys working on a cross-functional team
 
 
 
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