Associate Preclinical ADME Lead - Mechelen, Leiden, Romainville
In the Preclinical Development department, you will support the Development team and contribute to the transition of CF drug candidates to clinics.
In particular, within the matrix organization of Galapagos’ project management, you will:
- Ensure the interface with CROs to set up and monitor the progress of preclinical ADME and toxicokinetics studies (budget, schedule, protocol, results and report), in collaboration with colleagues of preclinical safety,
- Contribute to the preparation of nonclinical ADME related documentation for CTA/IND filings where relevant
- Contribute to the scientific and regulatory expertise to streamline the preclinical development plan, in alignment with international guidelines and regulatory expectations
- Contribute to anticipate and identify possible issues in the project development plans and propose alternative options
- Contribute to preclinical ADME expertise in strategic discussions with project alliance partners
- Contribute to communication with project teams and management.
The successful candidate
- is a biologist, pharmacist or veterinarian with a Master or PhD in Drug Metabolism and Pharmacokinetics and ca. 5 years or more of relevant experience in a CRO or pharmaceutical industry
- has in-depth understanding of in vitro and in vivo ADME assays, methods and models
- has good knowledge of GLP
- 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).