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:

The Clinical Operations Business Associate will report to the Director, Clinical Operations and will collaborate with cross-functional groups to develop and maintain business processes to ensure the Nonclinical and Clinical teams are innovative and adaptive in Immunovant’s approach to drug development while also compliant with regulatory expectations.

 

Key Responsibilities: 

 

  • Assist the Director, Clinical Operations with governance and oversight of vendors to achieve goals and ensure performance expectations are met. 
  • Develop vendor scorecards for each type of GCP and GCLP vendor.
  • Orchestrate vendor oversight and governance meetings for all GCP and GCLP vendors, including but not limited to CROs (both Clinical and Nonclinical), bioanalytical labs, recruitment vendors, etc.
  • Partner with Clinical, Nonclinical, Quality, and Regulatory teams in the development and continuous improvement of the GXP quality system, including SOPs, document management, personnel training, and quality processes.
  • Ensure timely completion of preventative and corrective actions associated with the Quality Plan.
  • Each year, assess all SOPs for applicability to current regulations and revise as needed, incorporating input from subject matter experts.
  • Monitor the Clinical Operations team’s compliance with existing SOPs, prepare mitigation plans to resolve any instances of non-compliance, and then monitor the execution and adherence to such plan.
  • Support the R&D organization on contract generation / reviews, preparation for Advisory Board meetings, and other ad-hoc project management efforts.

 

Requirements:

 

  • Bachelor’s degree required; degree with a focus in biological science
  • Minimum of 1-3 years progressive experience in clinical operations with thorough understanding of cross functional clinical processes including clinical supply, data management, biostatistics, and medical writing
  • Experience in project management is required
  • Ability to understand clinical trial from protocol writing through clinical study report completion independently
  • Previous trial execution experience in complex indications preferred
  • Global study execution and experience with various health and ethics agencies preferred
  • Experience in managing cross functional team members during trial execution
  • Strong knowledge in GCP and ICH and of the application process to conduct clinical trials
  • Ability to function in a fast pace, dynamic environment
  • Ability to deal with ambiguity
  • Ability to clearly develop action plans to ensure delivery on company strategy and goals as well as clinical development plans
  • Strong interpersonal and negotiation skills
  • Proven complex problem solving and decision-making skills
  • Must be a demonstrated self-starter and team player with strong interpersonal skills
  • Excellent written and verbal skills
  • Must display strong analytical and problem-solving skills


Work Environment:

 

This position has been filled.