Senior Director, Clinical Pharmacology

Establishes Clinical Pharmacology strategies that align with team goals and meet regulatory requirements (IND and NDA etc.).

Acts as the lead clinical pharmacologist for clinical stage programs; designs, conducts, and manages assigned clinical pharmacology (PK, PK/PD, PBPK, popPK, DDI, FE, and PK in special populations) and relevant DMPK studies and performs hands-on data interpretation.

Represents clinical pharmacology on multidisciplinary projects and provides scientific leadership and strategic direction to clinical programs.

Serves as the subject matter expert for clinical pharmacology in the development teams, including FIH by conducting human PK parameters and exposure projection using in vitro and animal PK data, estimating MRSD, designing optimal dose-finding strategy.

Develops and writes relevant documents including IB, protocols, study repor...