Medical Leader/Clinical Indication Leader
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), Switzerland (Basel) 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 Medical Leader/Clinical Indication Leader.
Scope of the job
Physician leading the clinical development of a drug candidate in a selected indication by providing guidance and expertise to the Clinical Development Team and the Clinical Study Team at Galapagos.
- Formulate, update, and execute the Clinical Development Plan for the assigned indication
- Lead the preparation of clinical study concepts, clinical study outlines and protocols, and other clinical documents
- Reporting to the Clinical Development Leader, closely collaborate with multidisciplinary project team members and other subject matter experts to drive the development of drug candidates in the assigned indication and for the execution of clinical studies
- Manage the interactions with external experts, collaborators, alliance partners to ensure the timely execution of the Clinical Development Plan
- Contribute, review, and approve all regulatory documents relevant to clinical studies for the assigned indication such as Briefing documents, IB, IMPD, IND, clinical study protocol, CSR, Clinical Summary documents for submissions (e.g., MAA/NDA)
- Contribute to prepare submission dossiers and interactions with the Competent Health Authority in close collaboration with regulatory leaders
- Contribute to identification and mitigation of safety risks as member of the safety management team and to preparation of the DSURs in collaboration with the Medical Safety Leader
- Provide medical input in vendors selection for the assigned clinical study and interact with medical counterparts
- Contribute to manage DMC (data monitoring committees), adjudication committees, other trial-related committees
- Contribute to writing/review of clinical study documents including CRF, site guidelines, laboratory manuals, etc.
- Provide training of CRAs, investigators, other trial personnel, and act as central point of contact for study-related medical questions
- Contribute to trial oversight by monitoring safety of trial’s participants and integrity of trial’s data
Who are you ?
- MD or MD/PhD 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
- Ability to travel for 25%
- 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…!