Principal Scientist, Pharmacokinetics (PK)

Job description

Position Description Summary: The Principal Scientist PK/QSP will lead and manage nonclinical PK/QSP strategies across multiple drug development projects. This role serves as the primary PK/QSP representative on interdisciplinary project teams and provides scientific leadership from early discovery through regulatory submission and market authorization. The Principal Scientist PK/QSP is responsible for the design, adequate budgeting, and monitoring of non-clinical PK/QSP studies conducted internally and externally both in a GLP and non-GLP environment Main Responsibilities: Serves as PK/ ADME/QSP representative on cross-functional project teams. Act as Nonclinical Development representative in Research Project teams. Acts as PK Study Monitor for external PK studies. Serves as technical expert for the PK/QSP organization in the application of advanced PK/PD, mechanistic, and disease modeling principles and methodologies, Performs advanced PK/PD modeling utilizing mechanistic and semi-mechanistic approaches to define the dose-concentration-efficacy/toxicity relationships, formulate various study design scenarios, and outcome prediction, to inform decision making. Leads study design d...