Preclinical Safety Lead

Job description

Ref: MEC 220 - RMV 130 

 

In the Preclinical Development department, you will support the Development team and contribute to the transition of Cystic Fibrosis 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 development
  • Plan for Preclinical Safety 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 Safety investigations with combinations
  • Represent Preclinical Safety 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 Safety studies
  • Ensure compliance with GLP requirements, regulations and RA guidelines
  • Contribute to the preparation of preclinical safety documentation for CTA/IND filings
  • Report to CF project team and management.

Requirements

The successful candidate is a biologist, pharmacist or veterinarian with a Master or PhD of Toxicology and at least 10-15 years of relevant experience in the pharmaceutical industry.
Previous experience with development of combination human therapies is strongly preferred.
He (she) enjoys working in cross functional teams and has excellent oral and written communication skills as well as good command in English (writing and speaking).