Clinical Biomarker Scientist
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 Clinical Biomarker Leader.
The Clinical Biomarker Leader will be a key contributor to the Clinical Development teams (CDTs), the Idiopathic Pulmonary Fibrosis (IPF) franchise, and the Galapagos development pipeline.
The Clinical Biomarker Leader (CBL) will be responsible for providing expertise and guidance on the most efficient biomarker development strategy on Galapagos’ drug candidates from the Early Phases of Development to Late Phases of Clinical Development. The CBL will be responsible for biomarker aspects of clinical studies for evaluation of new drug candidates in the area of Osteoarthritis, Inflammation, Atopic Dermatitis, Pain, Fibrosis and Metabolism.
This position reports to the Senior Vice President of Translational Medicine
- Transfer of biomarker knowledge between the Therapeutic Area in Drug Discovery/Translational Sciences and clinical teams in the abovementioned areas of which the most advanced is the IPF franchise.
- Closely collaborate with CDT members (Translational Medicine Leaders and Clinical Development Leaders) and the Therapeutic Area Head in Respiratory Medicine for the IPF franchise
- Collaborate with the Pharmacology Leader in the interpretation of the mode of action of Galapagos’ molecules through the analysis of (pre-) clinical biomarker data.
- Interact with the Therapeutic Area group in discovery in identifying new disease relevant pathways through the analysis of biomarker data.
- Lead the design of the clinical biomarker plan in clinical protocols being developed by the CDT for Phase 1 through Late Clinical Development including the IPF franchise
- Provide the Clinical Biomarker expertise needed to drive decision-making regarding safety and efficacy of new and advanced drug candidates in the various disease areas comprising the GLPG pipeline
- Contribute to planning of the collection of biomarker samples and development of the informed consent to take into account biobanking; supervise clinical biomarker activities undertaken internally or through CRO activities including sample and data management
- Participate in the statistical analysis plan and review of results related to biomarker data
- Contribute to the writing of the Clinical Study Report
- Collaboration with internal scientists and physicians internally and with leading academic experts externally, as needed to support the clinical projects in Early and Late Clinical Development and the IPF Franchise
The successful candidate will combine experience and inspirational leadership with a ‘can do’ attitude.
Furthermore the successful candidate is:
- A strategic thinker, with the ability to help set a vision and lead change
- An outstanding communicator with excellent management and influencing skills
- Scientifically and analytically very well skilled
- Decisive and performance driven, whilst working collaboratively
- A sound judger with high ethical standards
- Diplomatic and tactful
- A mentor
- Able to interact with authority and confidence at various levels both internally and externally
- Fluent in English in speech and writing
- Preferably a PhD with several years of experience in early phase drug development and translational medicine obtained at R&D Headquarters of biotechnology or pharmaceutical companies
- Relevant experience in the area of Osteoarthritis, Inflammation, Atopic Dermatitis, Pain, Fibrosis or Metabolism.
- Very good scientific foundation, preferably within Academia
- Experience level of at least 7 years in Clinical research and 5 years in Pharmaceutical Industry
- Solid understanding of drug development