Galapagos

Clinical Development Leader

Job information

Industry

Biotechnology

Job Type

Full Time

Experience

3-5 years min.

Location

Belgium

Degree Type

PhD

Degree Specialization

Clinical trials engineer

Description

We are looking for a Clinical Development Leader, a physician responsible for leading a multidisciplinary Clinical Development Team (CDT) and providing expertise and guidance on development strategy of 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
  • Closely collaborate with multidisciplinary project team members and other subject matter experts to drive the development of drug candidates across all phases of clinical development
  • Oversee and manage the interactions with external experts, collaborators, alliance partners to ensure the timely execution of the Clinical Development Plan
  • Oversee all phases clinical studies from planning, design, set-up, conduct, monitoring through reporting of study results
  • Contribute, review, and approve Briefing documents, IB, IMPD, study protocol, and CSR
  • Lead the Competent Authority and Ethics Committee/IRB submissions and interactions in close collaboration with regulatory leaders
  • Participate to the safety management team and contribute to the risk assessment and mitigation strategy for drug candidates in all phase of clinical development

Seer more details about this position and apply via the button below

1629895774627

We are a biotechnology company developing innovative medicines intended to improve people’s lives. We discover and develop new medicines in order to offer new and better treatment options to patients affected by inflammatory diseases, cystic fibrosis, metabolic diseases, fibrosis, and other diseases.

Biotechnology

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Key Values

  • Make it happen
  • Embrace change
  • Act as a pioneer
  • Raise the bar