Preclinical Safety Lead - Romainville

Job description

Ref RMV 182


In the Preclinical Development department, you will support the Development team and contribute to the transition of new drug candidates to clinics and their progression onto further steps of clinical development.


In particular, within the matrix organization of Galapagos project management, you will:

- Provide scientific and regulatory expertise to streamline the preclinical development plan of new drug candidates, in compliance with regulations, guidelines and RA expectations
- Ensure the interface with CROs to set up and monitor the progress of preclinical safety studies (budget, schedule, protocol, results and report)
- Ensure compliance with GLP requirements, regulations and RA guidelines
- Collaborate with the Project Leaders and Project Managers to identify potential issues and best ways‑forward for preclinical safety programmes

- Where relevant, represent Preclinical Safety expertise in strategic discussions with alliance partners

- Contribute to identification and selection external service providers (CROs) for preclinical Safety studies
- Contribute to the execution of CRO Master Audit and CAPA plans in close collaboration with the Quality and Compliance department Contribute to the preparation of preclinical safety documentation for CTA/IND filings
- Report to project teams and management.

Requirements

The successful candidate 


- Is a pharmacist, veterinarian or biologist with a a Master or PhD of Toxicology and ideally ca. 10 years of relevant experience in a CRO or pharmaceutical industry;

- Has in-depth understanding of regulatory toxicology and safety pharmacology programs

- Has good knowledge of GLP
- Enjoys working in cross functional teams and has excellent oral and written communication skills as well as good command in English (writing and speaking)