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:

The Clinical Pharmacology (CP) group is seeking a knowledgeable Associate Director, Quantitative Pharmacology (QP). This individual will provide support to the head of CP, responsible for delivery and quality of pharmacometrics (PMx) work at Immunovant. This person will apply state of the art modeling and simulation (M&S) approaches to influence the clinical study designs, as well as internal and external decision making. We expect this person to develop and apply quantitative frameworks that enable model-informed drug discovery and development (MIDD). The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup.

Key Responsibilities:

  • Plan and execute state-of-the-art M&S techniques with direct value in supporting the research and development (R&D), as well as regulatory submissions
  • Identify, develop, and report population pharmacokinetic (PopPK) and PopPK/pharmacodynamic (PopPKPD) models, as well as other modeling approaches and exposure-response (ER) analysis, to support internal and external decision making and regulatory submissions
  • Draft and finalize QP related report templates, as well as data handling and analysis standard operating procedures (SOP)
  • Together with the functional head, work closely with Regulatory to provide QP support of regulatory documents, communications, and presentations as needed (IND, health authority inquires, preparation/participation in meetings with health authorities, preparation of BLA PopPK/PopPKPD/ER sections, addressing review inquiries, health authority sponsored Advisory Committee Meetings)
  • Support and contribute to the development of the QP in terms of providing training and knowledge sharing within CP and across other functions as needed
  • Monitoring external and internal environment in terms of relevant new methodologies and applications
  • Ensure Immunovant modeling efforts are aligned with current regulatory expectation
  • Assist the Statistics, Data Management, Clinical, Preclinical/Nonclinical, Bioassay, as well as other functions, as needed


Requirements:

  • MS or PhD with training in PopPK and PopPKPD modeling, Statistics, Engineering, or other quantitative subject areas
  • 7+ years for MS or 5+ years for PhD of experience in the application of PMx in an industry drug R&D setting
  • Proficient in using PMx tools and software (e.g., WinNonlin, NONMEM, and R) for individual PK (e.g., noncompartmental analysis, NCA), PopPK, PopPKPD, ER analysis, and M&S
  • Previous modeling experience with monoclonal antibody (mAb) therapeutics with nonlinear PK profile
  • Strong written and oral communication skills with incredible attention to detail
  • Desire to work in a dynamic, interactive, fast-paced, innovative, and entrepreneurial environment
  • Natural collaborator who enjoys working on a cross-functional team
  • Domestic or international travel may be required (<10%)


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 or international travel may be required (<10%)

 

This position has been filled.