Director, Clinical Pharmacology
1 day ago
Organizational Overview:
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
The Role:
The Clinical Pharmacology (CP) group is seeking a knowledgeable Director, Clinical Pharmacology. 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:
- Remote-based
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel are required 10%
Compensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $235,000.00 to $250,000.00.
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