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 Manager 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 supporting the advancement of rare disease clinical trials as part of Immunovant’s Clinical Operations team. 


Key Responsibilities:  

  • Support the study feasibility and site selection process and in conjunction with the Sr. Director Clinical Operations.  
  • In collaboration with Sr. Director Clinical Operations, develop study operational strategies including vendor outsourcing approach. 
  • Assist with management of CROs and third-party vendors in line with study and program goals; including reporting metrics 
  • Review of study plans and documents to ensure compliance with GCPs, vendor and in-house procedures. 
  • Participate in site initiation visits 
  • Participate in co-monitoring visits with the CRO 
  • Assist clinical sites with questions and resolving queries. 
  • Ensure complete and inspection ready eTMFs throughout the duration of clinical trials 
  • Support management of study level budgets. 
  • Support development and follow through of effective clinical and safety data review plans throughout the study; as well as supporting development and implementation of corrective action plans to ensure good data quality. 
  • With oversight from the Sr. Director Clinical Operations, provide support to the multifunctional team and manage vendors to develop aggressively realistic timelines and ensure appropriate accompanying risk mitigation plans. 
  • 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, biostatistics, medical writing, drug safety, regulatory affairs, and legal considerations. 
  • Deep 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 Yorkoffice 
    • Dynamic, interactive, fast-paced, and entrepreneurial environment 
    • Domestic and international travel is required (up to 50%)