Medical Director - Basel, CH; Mechelen, BE or Leiden, NL

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Paris), the Netherlands (Leiden), Switzerland (Basel), Spain (Madrid), Italy (Milan), the UK (London), Germany (Munich) and in the 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 Medical Director - Basel, CH; Mechelen, BE or Leiden, NL

Scope of the job

As Medical Director you will initially be part of the late stage inflammation team in clinical research providing medical expertise, tactical and strategic input to development plans in a multi-disciplinary team setting to ensure timely planning, designing, conduct, and monitoring of clinical trials in Phase III. In this particular role, you will also closely collaborate with the medical affairs team on medical scientific communication of clinical trial data.

Your role

  • You'll be responsible for all medical aspects of clinical human studies from Phase 1 (excluding first-in-human) to Phase II studies in patients under evaluation at Galapagos through Proof of Concept. Possibility to extend expertise to Phase III clinical studies, depending on personal expertise and the progress of the assigned program.
  • You provide expertise and guidance on the most efficient early development strategies for Galapagos' drug candidates across all therapeutic areas including, but not limited to: Gastroenterology, Rheumatology and Inflammation
  • You focus on strategic design for Phase Ib/II/III studies that are calculated to:
    • meet PoC requirements
    • avoid false confidence by providing a risk assessment foundation for continued investment
    • capable of thoughtfully influencing the strategic decisions and designs for the next clinical trial phase(s)
    • meet regulatory and ICH requirements
  • You'll be involved in the compilation and assessment of clinical and scientific data (e.g., PK, PD and safety data) generated from Phase Ib/II/III clinical trials.
  • You closely collaborate with multidisciplinary Clinical Development Team and Clinical Study Team members to support the development of drug candidates in the Early phases of Development
  • You contribute to regulatory documents relevant to clinical studies such as Briefing documents, IB, IMPD, IND, clinical study protocol, CSR and Clinical Summary documents for submissions (e.g., MAA/NDA)
  • You contribute to the benefit risk assessment in the DSUR
  • You contribute Medical expertise to support decisions related to clinical development plan of one or more drug candidates assigned

Job requirements

Who are you?

  • MD or MD/PhD with 5 or more years of experience in clinical research that includes medical oversight of clinical trials
  • Experience in inflammation or specialization in gastroenterology or rheumatology preferred
  • Solid understanding of clinical development
  • Strong collaborative skills and a strategic thinker
  • Energetic with a can-do attitude
  • Strong scientific and analytical skills
  • Entrepreneurial, hands-on, with perseverance and problem-solving skills.
  • Able to work independently and effectively in complex, changing environments.
  • Flexibility, diplomacy, and the ability to manage expectations.
  • Strong presentation/interaction and time management skills.
  • Proven ability to establish strong partnerships with internal and external stakeholders.
  • Thorough understanding of GCP, as well as a sound ethical approach to business.
  • A genuine passion for science and in making a difference in patient's lives.
  • Fluent in English

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…!