Clinical Development Leader

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
• …