Organizational Overview:

Immunovant is a publicly traded, clinical stage biopharmaceutical company committed to developing innovative therapies for patients living with autoimmune diseases. We are developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of multiple autoimmune diseases that are mediated by pathogenic IgG antibodies. Phase 2 clinical development is ongoing with Phase 3 preparations underway.

The Role: 

Immunovant is seeking a Clinical Trial Assistant to play a key role on a highly dynamic cross-functional team. Reporting to a Sr. Director of Clinical Operations, you will be responsible for administrative support in the advancement of rare disease clinical trials as part of Immunovant’s Clinical Operations team from study start-up to study closure. 
 

Key Responsibilities: 


  • In collaboration with Sr. Director Clinical Operations, support the study operational strategies. 
  • Assist with budget monitoring including invoicing and confirmation of site payments. 
  • Develop meeting agendas, minutes and track follow-up actions 
  • Ensure eTMF oversight including routine quality checks to maintain a complete and inspection-ready state. 
  • Maintain a vendor and site contact list 
  • Work with the clinical operations team to maintain clinical trial scorecards for routine review 
  • Assist clinical sites with questions and resolving queries. 
  • With oversight from the Sr. Director Clinical Operations, provide support to the multifunctional team on special initiatives as needed. 
  • Create and improve upon business processes ensure Immunovant’s successful growth 


Requirements: 

  • BA/BS in a clinical or scientific discipline; at least 3 years of experience with clinical trials; working with a sponsor company (biotech/pharmaceutical company) 
  • Additional experience in other related fields or positions, some phase 2/3 and global clinical trial experience is a plus. 
  • Understanding of FDA, EMEA, ICH and GCP guidelines, as well as cross-functional clinical processes including clinical supply, data management, and drug safety. 
  • Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent. 
  • Understanding of clinical trial operations and management of clinical trials at investigator sites  
  • Multitasking ability to oversee a large number of projects and reach milestones on time 
  • Exceptional academic and professional accomplishments, indicating critical thinking ability 
  • Strong written and oral communication skills with incredible attention to detail 
  • Willingness to roll up your sleeves and get in the weeds of projects as a jack of all trades 
  • Ability to think outside of the box and challenge the status quo 
  • Natural entrepreneurial spirit with unrelenting dedication to delivering results 
  • Desire to work in a fast-paced, innovative environment 
  • Natural collaborator who enjoys working on a cross-functional team 

 

ShapeWork Environment 

    • The position is located at Immunovant’s New York Office 
    • Dynamic, interactive, fast-paced, and entrepreneurial environment 
    • Domestic and international travel is required (10%) 
This position has been filled.