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 Pharmacology (CP) group is seeking a knowledgeable Quantitative Pharmacology (QP) Scientist. 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, PhD, or PharmD with training in PopPK and PopPKPD modeling, Statistics, Engineering, or other quantitative subject areas
  • 2-7+ for MS or 0-5+ years of experience in the application of PMx in a 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) and PopPK analysis, and M&S
  • Previous modeling experience with monoclonal antibody (mAb) therapeutics with nonlinear PK profile is preferred
  • Good 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

 

Work Environment:


This position has been filled.