Director, Infectious Diseases and Vaccines, Quantitative Pharmacology and Pharmacometrics

Job description

Job Description Directors in Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics , inform dose selection and go/no-go decisions, and shape, present and defend regulatory strategies to support global regulatory submissions and post-approval expansions in indications . Directors perform job duties independently with minimal supervision, lead QP2 efforts on drug development programs, and author strategic documents. Directors are expected to have or be developing expertise in several areas, including: Serving as an expert representative for QP2 on teams developing infectious disease or vaccine assets Framing critical drug development questions for optimizing model-based development Developing and executing translational PK/PD models, population pharmacokinetic models, exposure-response and, stratification biomarker models, quantitative system pharmacology (QSP) and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, comparator modeling, absorption/biopharmaceutical modeling, clinical utility index modeling, and...