Director - Clinical Pharmacology

July 24, 2024

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Immunovant

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Immunovant is a company focused on advancing treatments for autoimmune diseases through a patient-focused approach. With a vision of enabling normal lives for people with autoimmune diseases, Immunovant applies its expertise in science to develop and test new therapies. The company emphasizes complex and variable needs across different stages and severities of diseases. Immunovant is committed to pushing forward its therapeutic areas and clinical trials, while also engaging with patients, caregivers, and investors about their ongoing studies and corporate initiatives.

Biotechnology Research

51 - 200 employees

Founded 2018

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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 • 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 closely with Regulatory to provide CP support of regulatory documents • Work closely with Quantitative Pharmacology (QP) colleagues to develop and deliver agreed quantitative strategies • 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 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) • 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

🏖️ Benefits

• Equity, sign-on bonuses, and other forms of compensation • Full range of medical, dental, vision, 401k and other benefits • Unlimited paid time off • Parental leave