Immunovant is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases. Immunovant is developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.

 

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 and 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, and 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.


Responsibilities:

  • Planning, implementation and 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, and leverage positive working relationships to enable robust sourcing strategies for future studies
  • Contribute to the design, preparation, and finalization of clinical protocols, study manuals, study reports and 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 and GCP regulations is required
  • Experience with vendor and investigator contracting and budgets
  • Experience selecting and oversight of CROs/vendors required
  • Experience in rare disease therapeutic areas and 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 and action
  • Willingness to roll up your sleeves to get the job done

 

This position has been filled.