Director, Quantitative Pharmacology, Clinical Pharmacology

Job description

Job Summary Oversees all clinical pharmacology activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. Leads study design, execution and reporting of clinical pharmacology and studies. Provides input into all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response and pediatric development. Closely interacts with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance and drug interaction studies. Author/reviewer of clinical pharmacology submission documents and representative of the department at different product development team meetings. participates in pharmacometrics and simulation and modeling plans and 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: - Lead clinical pharmacology activities related to study design, protocol development, study execution, reporting and interpretation of data. - Conduct PK and PK/PD analysis . - Work closely with pharmacome...