Clinical Development Leader - Mechelen (BE) or Basel (CH)

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden) and in US, Boston.

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.

Scope of the job:

Physician responsible for leading a multidisciplinary Clinical Development Team (CDT) and providing expertise and guidance on development strategy of drug candidates through the Late Phases of Clinical Development at Galapagos.

Your role:

  • Lead the Clinical Development Team to design and execute the Clinical Development Plan from Phase 2 through registration
  • Closely collaborate with multidisciplinary project team members and other subject matter experts to drive the development of drug candidates in late phases of clinical development
  • Manage the Medical Leaders assigned to the CDT
  • Oversee and manage the interactions with external experts, collaborators, alliance partners to ensure the timely execution of the Clinical Development Plan
  • Oversee all phases of Phase 2 and Phase 3 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 late phase of clinical development

#LI-LB1

Requirements

Who are you ?

  • Physician with 5 to 10 years of experience in clinical research
  • Specialty or clinical experience in autoimmune or respiratory disease areas preferable
  • Solid understanding of clinical Phase I – III drug development
  • At least 5 years of clinical development experience in the Pharmaceutical industry
  • Strong collaborative skills and a strategic thinker
  • Energetic with a can-do attitude
  • Strong scientific and analytical skills
  • Location: Basel or Mechelen.

What’s in it for you ?

You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

We are Galapagos : together we can make it happen…!