Description

The Scientist PK is responsible for monitoring of non-clinical PK/TK studies conducted internally and externally both in a GLP and non-GLP environment and support modelling activities

Main Responsibilities:

Design, oversee, and interpret nonclinical PK/QSP studies (GLP and non-GLP) to support regulatory submissions and drug development.
Conduct PK, PBPK, QSP modelling and/or work with external collaborators.
Prepare and review regulatory nonclinical submission documents.
Collaborate with internal stakeholders including pharmacology, toxicology, clinical, regulatory, and CMC teams.

Qualifications and Experience Requirements:

Bachelor’s, Master’s, or Ph.D. in Life Sciences or related subject area with 3+ years of pharmaceutical development experience in pharma, biotech, or CRO, with a focus on modeling and simulation.
Training in PK/PD, modelling and simulation, using industry standard software pac...