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:

As the Clinical Supply Manager, you will manage all aspects of the supply chain for assigned projects in support of the planning, execution, and close out of Phase I - IV clinical studies to ensure the objectives of the studies are met.

Key Responsibilities:

  • This position will manage the relationship with external CMO’s and oversee the supply chain manager there.
  • Develop and apply the distribution strategy (for IRT and non-IRT studies) that ensures continuity of IP at depots and investigational sites.
  • Ensure all critical parameters are considered for every distribution strategy; IRT specifications (e.g., initial or resupply quantities); any QP, project, study, expiry, customs, import/export, brokerage, or country specific requirements.
  • Work with relevant departments to create master labels for each study.
  • Ensure adequate stock at depot and site levels.
  • Support relabeling activity or transfers between sites.
  • Generate and/or review shipment requests for accuracy & completeness prior to issuance.
  • Ensure accuracy of IP receipt for all shipments and availability in IRT for applicable studies.
  • Serve as point of contact for Returned Products.
  • Ensure final drug reconciliation is completed and accurate at site, depot and study level.
  • Serve as point of contact for all distribution activities.
  • Provide adequate communication and documentation relevant to the clinical study plan and the movement of all investigational products.
  • Contribute to the budgeting and forecasting for all clinical studies.
  • Offer creative solutions/proposals to optimize the clinical supply chain.
  • Generate and maintain data for clinical distribution metrics.


Requirements:

  • Bachelor's degree from an accredited college or university.
  • 3 years of health sciences experience is required; pharmaceutical industry or related experience is preferred; work in the areas of clinical operations, and/or project management a plus.
  • Demonstrated knowledge of the pharmaceutical business and ability to anticipate environmental changes and trends and implement changes accordingly.
  • Demonstrated excellent knowledge of clinical study protocols and IP related activities with particular emphasis on global distribution and strategy.
  • Proven thorough understanding of GMP, GDP (IP production and distribution) as well as a thorough understanding of IRT systems.
  • Proven solid understanding of CMC and clinical study conduct activities.
  • Demonstrated excellent ability to interface with customers and distribution partners (couriers, brokers, vendors).
  • Proven ability to multitask and prioritize workload within a dynamic, timeline driven, culturally diverse organization.
  • Proficiency using Microsoft Outlook, Word, Excel, and PowerPoint.
  • Proven high attention to detail.
  • Demonstrated strong problem-solving skills


Work Environment:

  • The position will be located in Immunovant’s NY office 
  • Dynamic, interactive, fast-paced, and entrepreneurial environment 
  • Domestic or international travel is required (~10%)

 

This position has been filled.