Scientist, Clinical Pharmacology and Pharmacometrics

Switzerland
Posted 9 months ago

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

Job Features

Job CategoryCLINICAL DEVELOPMENT

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