Scientist, Clinical Pharmacology and Pharmacometrics

Key responsibilities

• Manage finance, budget and timelines related to assigned clinical pharmacology and pharmacometrics activities
• Design, plan, manage (oversight of contractors when applicable) and report the pharmacometrics
• studies (Non-Compartmental PK analysis, Population PK, PK/PD, Exposure/Response, Probability
• of Target Attainment, PBPK, Modelling & Simulation) of DPI compounds in development
• Manage the clinical pharmacology and pharmacometrics part of assigned clinical studies
  • Participate in the study design with regard to clinical pharmacology aspects
  • Participate in the preparation of informed consent forms, clinical protocol, SAP and CSR,
  • and other study-related documents
  • Determine, implement and manage the PK or PK/PD data analyses and reporting according to GCPs and regulatory guidelines
  • Contribute to the medical data review with regard to clinical pharmacology aspects (risk of drug-drug interactions and management of concomitant medications)
  • Ensure adequate filing of pharmacometrics study documents in the e-TMF
  • Be a member (as Clinical Pharmacologist) of one or more Clinical Study team(s)
• Manage outsourcing activities to an international network of CROs (Europe, Asia and America) or through academic collaborations (preparation of RFP, contractors selection, contracts review and budget negotiation)
• Contribute to the preparation of clinical pharmacology and pharmacometrics documentations to support the cross-functional activities (including PK chapters of regulatory documents
• Participate in external scientific communications (publications, poster and oral presentations, and press releases)
• Contribute to in/out licensing activities and external fund-raising activities

Your profile

• PharmD, PhD or an equivalent degree in pharmacokinetics, pharmacology, life sciences or a related discipline with a minimum of 5 years experience in clinical pharmacology or pharmacometrics within Translational R&D
• Excellence knowledge of GCP, GCLP, GLP and ICH guidelines
• Knowledge of Regulatory Affairs (EMA, FDA…) is a plus
• First experience in project management
• Strong communication & presentation skills
• Very good communication & influencing skills (oral and written)
• Fluency in English (both oral and written)
• Strong team player, looking to drive further projects and innovation