Preclinical ADME Lead - Mechelen,BE/Leiden,NL/Romainville,FR
Ref: RMV 219
In the Preclinical Development department, you will support the Development team and
contribute to the transition of drug candidates to clinics.In particular, within the matrix organization of Galapagos project management, you will:
- Provide scientific and regulatory expertise to streamline the preclinical developmentplan for ADME investigations of combination therapies, in compliance with regulations,guidelines and RA expectations
- Collaborate with the Project Leader and Project Managers to identify issues and best ways-forward for Preclinical ADME investigations with combinations
- Represent preclinical ADME expertise in strategic discussions with the alliance partner
- Collaborate with the other Preclinical Development representatives in the CF team to set up investigation plans and study designs
- Contribute to identification and selection CROs external service providers for preclinical ADME studies
- Ensure compliance with GLP requirements, regulations and RA guidelines
- Contribute to the preparation of nonclinical ADME related documentation for CTA/IND filings
- Report to project team and management.
The successful candidate
- Is a biologist, pharmacist or veterinarian with a Master or PhD in Drug Metabolism and Pharmacokinetics and at least 5-10 years of relevant experience in
the pharmaceutical industry;
- Has in-depth understanding of in vitro and in vivo ADME assays,
methods and models. Previous experience with development of combination human
therapies is strongly preferred.
- He/She enjoys working in cross functional teams
- He/She has excellent oral and written
communication skills as well as good command in English (writing and speaking).