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Roivant Sciences // biomedical research
 
Roivant Sciences, 324 Blackwell Street, Bay 12, Suite 1220, Durham, NC 27701, United States    Posted: Wednesday, November 06, 2019
 
   
 
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Immunovant, a subsidiary of Roivant Sciences, is a clinical stage biopharmaceutical company committed to developing innovative therapies for autoimmune diseases. Our lead asset, IMVT-1401, is in phase 2 clinical development for the treatment of multiple autoimmune diseases, with additional trials expected to start this year.

Immunovant is seeking a Director, Clinical Operations to play a key role on a highly dynamic cross-functional development team. The individual in this role will drive the operational planning, implementation & conduct of Phase 1 through 4 studies. The position requires the ability to manage all aspects of clinical study operations including protocol development, CRO oversight/selection, budgets, timelines, contracts, study set-up, study conduct, & reporting. The individual may lead multiple programs requiring the ability to multi-task on a wide spectrum of activities. This role will be based in either Durham, NC or New York, NY.

Responsibilities:

  • Planning, implementation & conduct of clinical studies
  • Lead the CRO/vendor selection strategy to support assigned studies, manage the documentation for contracting process (SOWs, MSAs, etc.), ensure sponsor oversight, & leverage positive working relationships to enable robust sourcing strategies for future studies
  • Contribute to the design, preparation, & finalization of clinical protocols, study manuals, study reports & other key operational/regulatory documents
  • Serve as an integral member of the Project Team, coordinating activities across functional areas as required

Requirements:

  • BS degree or higher
  • At least 7 years of experience in the pharmaceutical industry, with at least 1 year in a clinical leadership role on a cross-functional drug development project team
  • Experience working across all phases of clinical research (Phases 1-4) preferred
  • Working knowledge of ICH & GCP regulations is required
  • Experience with vendor & investigator contracting & budgets
  • Experience selecting & oversight of CROs/vendors required
  • Experience in rare disease therapeutic areas & patient engagement strategies preferred
  • Occasional traveling (< 20% of time) including potential international travel

Qualifications/Critical characteristics include:

  • Deeply motivated self-starter with an entrepreneurial spirit
  • Desire to work in a quickly changing, fast-paced environment
  • Unrelenting dedication to delivering quality results
  • Integrity, in word & action
  • Willingness to roll up your sleeves to get the job done
 
 
 
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