Director - Clinical Pharmacology
July 24
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
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