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Mechelen

    Clinical Development Leader - Mechelen, België - Galapagos

    Galapagos
    Galapagos Mechelen, België

    1 week geleden

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    Beschrijving

    Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices across Europe and headquartered in Belgium (Mechelen) .

    We're 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: The 'make-it-happeners'.

    We are looking for a Clinical Development Leader to join our team in Basel (Switzerland) or Mechelen (Belgium).

    Scope of the job

    Physician leading the creation and execution of the clinical development plan for drug candidates at Galapagos.

    Your role

  • Lead the Clinical Development Team to define the clinical development strategy as well as design and execute the Clinical Development Plan from FIH through registration according to approved plans including budget and timelines
  • Drive the process of expanding the indication spectrum beyond the initial indication by building a strong preclinical and clinical rationale for additional diseases or conditions
  • Support the identification of opportunities to grow & sustain the GLPG portfolio
  • Provide scientific guidance and contribute to regulatory interactions including applications for marketing authorization
  • Contribute, review, and approve Briefing documents and the IB and contribute and review IMPD, study protocol, CSR and other documents
  • Closely collaborate with multidisciplinary project team members and other subject matter experts
  • Oversee and manage the interactions with external experts, collaborators, alliance partners, participate in Due Diligences
  • Participate to the safety management team and contribute to the risk assessment and mitigation strategy for drug candidates in all phases of clinical development
  • Support to attract, retain and develop top talent for the Clinical Development group
  • Line Manager role (as applicable)
  • Function as Clinical Program Head (CPH) delegate (as applicable)
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