Organizational Overview:

Immunovant is a clinical-stage biopharmaceutical company with a company vision focused on enabling normal lives for patients with autoimmune diseases. Our lead asset, IMVT-1401, is a novel, fully-human, anti-FcRn monoclonal antibody in clinical development for multiple indications, delivered as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies. Immunovant is committed to developing innovative therapies that not only treat the symptoms but modify the course of autoimmune diseases, while restoring hope and health to patients with autoimmune disease by developing and delivering high-value restorative therapies that enable them to live normal lives.

The Role:

Immunovant is seeking an Associate Director, Clinical Laboratories who will be responsible for the day-to-day management of bioanalytical vendors supporting our clinical studies. Key duties are study set up, handling/oversite of vendors, critical reagent management and close-out responsibilities. This role works closely with the Director, Clinical Laboratories to ensure on-time seamless delivery of validated bioanalytical assays to enable analysis in support of our clinical programs. 

Key Responsibilities: 

  • Lead scientists at a contract laboratory for biomarker method development, validation and sample analysis in the regulated environment (GLP, GCLP or CLIA).
  • Provide strong technical support to the contract laboratory on different biomarker platforms. Ability to trouble-shoot and solve technical and instrumental issues.
  • Find, assess and bring online new vendors as needed in support of new biomarker and/or clinical programs
  • Work closely with cross-functional project teams to provide technical input during clinical protocol development
  • Ensure high-quality laboratory procedures, documentation and regulatory compliance
  • Review bioanalytical documentation that includes study protocols, analysis plans, data packages, validation study reports and sample analysis reports.
  • Coordinate study start-up and study close out operations at central and specialty laboratories 


Requirements:

  • Master’s degree or PhD in a scientific field and/or appropriate experience
  • 5+ years of Assay Development experience preferred at pharma, biotech or clinical laboratories
  • Clinical trial laboratory start-up, oversight and closeout strongly desired
  • Hands-on experience and knowledge of method development / validation for supporting regulated studies; GLP and GCLP/CLIA experience a plus
  • Solid understanding of drug development; Phase 1-3 clinical program experience preferred
  • Experience with cross functional collaborations and the ability to present data/conclusions and lead scientific teams remotely preferred
  • Multitasking ability to oversee multiple projects and reach milestones on time
  • 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
  • Natural collaborator, great interpersonal skills and team player who enjoys working on a cross-functional team

 

Work Environment:

  • Immunovant’s headquarters is located in New York City.  The position is flexible for remote work.
  • Dynamic, interactive, fast-paced, and entrepreneurial environment
  • Domestic and international travel are required (~10%)

 

This position has been filled.