Senior Pharmacometrics Leader

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville & Paris), the Netherlands (Leiden), Switzerland (Basel), Italy (Milano), Spain (Madrid), the UK (London), Germany (München), and in the US (Boston).

We are 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 Senior Pharmacometrics Leader, Romainville, FR/Leiden, NL

Scope of the job

In the Pharmacometrics group within the Clinical Pharmacology Department, you will contribute to the characterization of pharmacokinetics (PK) and pharmacodynamics (PD) of novel drug candidates.

Your principal accountabilities will be:

  1. Ensure the timely delivery of translational PKPD, PBPK, population PK, exposure-response analysis, and model-based meta-analysis to support key development questions addressing efficacy and safety of drugs in development
  2. Execute PKPD and PBPK modeling and simulation sections in regulatory submissions
  3. Scientific and strategic input into pre-clinical, clinical, and post-approval development plans
  4. Close collaboration with preclinical scientists, translational medicine experts, Clinical, Biostats, CMC, commercial and regulatory to ensure optimal integration of modeling and simulation to address key clinical questions to support drug development
  5. Work with other scientists to prepare and review modeling and simulation reports and other clinical pharmacology documents
  6. Contribute to clinical protocols and clinical pharmacology and pharmacokinetic sections of regulatory documents, including INDs, NDAs, briefing book packages, Investigator Brochures, etc.
  7. Assist with the design, analysis, and interpretation of studies involving sparse sampling and provide guidance to optimize sampling strategies

You will report to the Head of Pharmacometrics and work in close collaboration with Clinical Pharmacology Leaders and other team stakeholders (such as Physicians, Biostatisticians).

Job requirements

The ideal candidate for this job has:

  • PhD or Master in Pharmacokinetics, Clinical Pharmacology or related field with a specific focus on pharmacokinetics and PK/PD modeling with at least 8 years’ experience in Clinical Development in Pharmaceutical Industry, Contract Research Organizations or academia
  • Hands-on experience with one or more PK, PK/PD software packages (Monolix, R, NONMEM or similar)
  • Good understanding of PBPK software (PKsim, SimCyp, Gastroplus) and clinical trial simulations
  • Experience with pediatric drug development programs and late phase drug development is a plus

You know how to work independently and within a team. Your sense of urgency allows you to handle dynamic planning and high pressure in competitive projects.

You have good written and oral communication skills in English and are able to understand the preferred local language at either the site in Romainville or in Leiden. 

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…!