JobMesh

Associate Director, Quantitative Pharmacology, Pharmacometrics

Otsuka Pharmaceutical Companies · Princeton, Florida, US

Job Summary Supports all pharmacometrics activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. Conducts analysis, execution and...

Job description

Job Summary Supports all pharmacometrics activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. Conducts analysis, execution and reporting of pharmacometrics studies. Provides input into all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response and pediatric development. Author of clinical pharmacology and pharmacometrics submission documents and representative of the department at different product development team meetings. Conducts pharmacometrics and simulation and modeling activities to provide input on modeling and simulation activities. Interacts with early development and business development team members as well as external collaborators to assess/lead development and selection of pre-IND and early phase assets. Job Description: Conducts pharmacometrics activities related to study design, protocol development, study execution, reporting and interpretation of data. Conducts population PK, PK/PD and modeling and simulation . Provides pharmacometrics analysis and participates in activities related to analysis and reporting of population PK and PK/PD analyses . Authors pharmacometrics sections o...