Preclinical Safety Leader - Romainville,FR/Basel,CH/Leiden,NL

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Switzerland (Bazel) and in US, Boston

 

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before.  In every challenge we face, we see new opportunities.  We want to challenge the impossible.  We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters.  Collaborative innovators and perseverant idealists. We need the best-in-class.  In other words, we need you.

 

We are looking for a Preclinical Safety Leader - Romainville, FR/Leiden, NL/Bazel, CH/Mechelen, BE

Scope of the job

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 programs
  • 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

Who are you?

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

What’s in it for you?

 

You will be part of a fast growing and amazing company.  As ‘make-it-happener’ you will get all the support you need to make your job successful.  At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

 

We are Galapagos : together we can make it happen…!