Director, Clinical Pharmacology

Summary

Join Immunovant, Inc., a clinical-stage immunology company, as their Director, Clinical Pharmacology. This role involves providing strategic and scientific expertise in clinical pharmacology, supporting clinical development programs, and collaborating with cross-functional teams. You will develop and maintain CP strategic plans, conduct PKPD analyses, and contribute to regulatory submissions. The position offers the opportunity to work in a fast-paced biotech startup environment. The ideal candidate will have a PhD, PharmD, or MD with extensive experience in clinical pharmacology and monoclonal antibody programs. A remote work environment is offered, along with a competitive salary and benefits package.

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 monoclonal antibodies programs
• Strong experience with TMDD modeling
• 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)
• 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

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

Preferred Qualifications

Previous experience with monoclonal antibody (mAb) therapeutics in autoimmune diseases

Benefits

• Full range of medical, dental, vision
• 401k
• Unlimited paid time off
• Parental leave
• Equity and other forms of compensation may be provided as part of a total compensation package
• Remote-based