Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Our pipeline comprises Phase 3, 2, 1, pre-clinical and discovery studies in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications. We have discovered and developed filgotinib: in collaboration with Gilead we aim to bring this JAK1-selective inhibitor for inflammatory indications to patients all over the world. Galapagos is focused on the development and commercialization of novel medicines that will improve people’s lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 480 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. More information at www.glpg.com.
For our site in Romainville or Mechelen, we are looking for a
Clinical Pharmacology Lead
Ref : RMV-118 (M/F, full time temporary contract)
Within the Clinical Pharmacology group, you will contribute to the characterization of pharmacokinetics (PK) and pharmacodynamics (PD) of novel drug candidates.
Your principal accountabilities will be:
1. Management and monitoring of the outsourced PK and PD activities in support to clinical development plan
2. Analysing, interpreting and reporting PK/PD data from clinical studies
3. Collaborating and guiding the Clinical team to set-up, data analysis and reporting for clinical studies.
4. Preparing and/or reviewing PK/PD components of internal documents, briefing books and regulatory submission documents (e.g. IB, IND, NDA and other regulatory documents)
5. Represent the Clinical Pharmacology group on multi-disciplinary Development Project Teams, providing appropriate PK/PD input and contribution to solve potential PK/PD issues and ensure timely and efficient progression of projects.
6. Actively preparing, reviewing and publishing scientific papers and abstracts
You will report to the Clinical Pharmacology Head and work in close collaboration with statisticians and physicians from the Clinical development group.
The ideal candidate for this job has:
- a PhD or Master in relevant disciplines (PK, PD)
- at least 10 years’ experience in Clinical Development in Pharmaceutical Industry or Contract Research Organizations
- a strong understanding of pharmacokinetics and pharmacodynamics (PKPD) principles..
- Hands-on experience PK/PD software packages (Phoenix)
You have the capability to work as an expert and share your expertise with other team members. You know how to work independently and within a team. You are used to work in project mode, including with geographically distant teams.
Your reactivity allow you to handle short delay and high pressure in competitive projects.
You have a good written and oral communication, both in English and French. If you are interested in joining a dynamic, open-minded, fast paced, exciting working environment, Galapagos offers you a competitive package.
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.
Do you have the qualifications for this job opening and are up to the challenge of joining our entrepreneurial team? If so, please send your application in English (preferably by e-mail) to:
102 avenue Gaston Roussel
AFPT-Club Phase 1
French association of the professionals of human and translational pharmacology
34, avenue des Champs-Elysées 75008 Paris 8ème, France
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