Responsibilities

The Pharmacokinetics Senior Specialist II will conduct advanced PK/PD modeling and simulation research, support product development through dose-concentration-pharmacological effect relationship definition, perform population PK/PD analyses in support of regulatory submissions, develop and review study designs, write analysis plans and reports, and analyze and interpret PK/PD data and results. They will also identify opportunities to address drug development questions/issues, maintain liaisons within and outside the organization, represent the organization on scientific matters, and prepare pharmacokinetics documents for regulatory submissions and responses to Agency questions.