Typical Accountabilities
Perform routine M&S work to support drug development projects based on CDE guidance of model-informed drug development (MIDD); contribute to the implementation of MIDD concepts to support optimal dose/dosing regimen selectionConduct population PK-PD, dose-exposure-response analyses to support drug NDA submission; conduct translational/mechanism-based modelling activities for mechanistic understanding of drug candidates of different targets and modalitiesCommunicate with cross-functional teams for model interpretations, modeling ideas and resultsProvide pharmacometrics input in regulatory documents (, briefing book, modeling reports for IND/NDA submissions)Education, Qualifications, Skills and Experience
Essential
Master/PhD in quantitative disciplines such as pharmacometrics, pharmacology, mathematics, engineering and statisticsWorking knowledge of other areas (pharmacokinetics [P...