DMPK and Bioanalysis Project Manager
RBW Consulting
Rennes
RBW are currently partnered with a growing biotech that are currently searching for a DMPK and Bioanalysis scientist to join their team. This is a fantastic opportunity for an experienced DMPK professional to lead a laboratory and develop first in class molecules.
Responsibilities:
- Design and execution of preclinical and clinical DMPK studies
- Oversee a lab of 2-3 scientists conducting PK and bioanalysis studies
- Manage outsourcing of DMPK studies to CROs
- Contribute to IND enabling and safety pharmacology studies for entering phase 1.
- Authoring of regulatory submissions and dossiers including IND, IB etc
- Conduct PK modelling and simulation for first in human dosing
Requirements:
- PharmD with 5 years industry experience contributing to DMPK
- Track record of advancing molecules from DMPK perspective across preclinical development
- Expertise in bioanalytical techniques including LC-MS/MS
- Knowledge of requirements for GLP regulatory environment
- Experience with Phoenix WinNonlin is desirable.