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 CP Scientist. This individual will provide support to the head of CP, providing strategic and scientific expertise, representing CP in the highly dynamic cross-functional clinical development team, as well as collaborating with both internal and external stakeholders to deliver the tactical execution of our CP strategy. This position will provide CP subject matter support to new and on-going clinical programs. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup.

Key Responsibilities:

  • Develop and maintain comprehensive CP strategic development plans for assigned clinical development programs/studies
  • Provide CP subject matter expertise to the clinical study team/development team.
  • Draft and finalize CP related report templates, as well as data handling and analysis standard operating procedures (SOP)
  • Participate in the drafting, review, and finalization of clinical study protocols and study analysis plans (SAP)
  • Supervise and/or conduct pharmacokinetic/pharmacodynamic (PKPD) analyses.
  • Draft, review, and finalize CP study reports and publications. Work with the Medical Writers to incorporate PKPD sections into clinical study reports (CSR)
  • Work closely with Regulatory to provide CP support of regulatory documents, communications, and presentations as needed (IND, health authority inquires, preparation/participation in meetings with health authorities, preparation of BLA summary sections, addressing review inquiries, health authority sponsored Advisory Committee Meetings)
  • Work closely with Quantitative Pharmacology (QP) colleagues to develop and deliver agreed quantitative strategies to support assigned development plans
  • Assist the Statistics, Data Management, Clinical, Preclinical/Nonclinical, Bioassay, as well as other functions, as needed


Requirements:

  • PhD, PharmD, or MD with training in CP, PKPD, Pharmacology, and Pharmaceutical Sciences
  • 5+ years of experience in the application of CP within the context of drug development in the healthcare industry
  • Expertise with PK, immunogenicity, drug-drug interactions (DDI), bioavailability (BA)/bioequivalence (BE), special populations, and dose selection
  • Hands on experience in using pharmacometrics (PMx) tools and software (e.g., WinNonlin, NONMEM, and R) for individual (e.g., noncompartmental analysis, NCA) and population PK (PopPK) analysis, modeling, and simulations (M&S)
  • Previous experience with monoclonal antibody (mAb) therapeutics in autoimmune diseases is preferred
  • Knowledge of current practices, regulatory requirements in clinical development, bioanalysis, biopharmaceutics, pharmacology, toxicology, and formulation development
  • Excellent written and oral communication skills with incredible attention to detail
  • Strong 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:

  • 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.