Clinical Pharmacology (Senior) Lead - Mechelen, Leiden, Romainville

Job description

Ref : RMV-136

 

We are looking for several candidates with 5 to 15 years experience to strengthen our Clinical Pharmacology group. 

 

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.

Requirements

The ideal candidate for this job has:

● a PhD or Master in relevant disciplines (PK, PD)

● at least 5 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.