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), Basel (Switzerland), Italy, Spain, Germany, UK 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.
We are looking for an Clinical Biomarker Leader - Inflammation and/or Fibrosis.
Scope of the job
You contribute to cross-functional teams with Research Scientists and Development functions, such as Clinical Development Teams (CDTs) and Autoimmunity/Inflammation disease project teams.
You support the clinical biomarker development and implementation plan in clinical studies, providing expertise and guidance on the most efficient biomarker strategy for drug candidates in the area of Osteoarthritis, Inflammation, Autoimmune diseases, Atopic Dermatitis, Pain and Metabolism.
• Ensure the transfer of biomarker knowledge and drug mode of action between the therapeutic area in Drug Discovery/ Translational Research and Clinical Research teams with respect to Inflammation and Autoimmune diseases or related fields, such as Osteoarthritis, Atopic Dermatitis, Pain or Metabolism.
• Develop and maintain effective working relationships with internal teams (research and clinical) and supporting functions, with particular focus on the Clinical Development Team (CDT) and external CROs/biomarker vendors.
• Interact with the Therapeutic Area group in discovery towards identifying new disease relevant pathways, new biomarkers through the interpretation of large clinical and biological data sets.
• Provide the necessary clinical biomarker expertise to drive decision-making regarding safety and efficacy of new and advanced drug candidates in several disease areas.
• Support the biomarker strategy with design of the clinical biomarker plan for clinical studies under development by the CDT, from Phase 1 through Late Clinical Development.
• Contribute to effective communication and presentations within cross-functional teams and writing/review of biomarker sections within clinical protocols, reports, etc.
• Define the strategy for collection of biomarker samples and in close collaboration with the clinical biomarker operations manager and procurement specialists perform CRO evaluation/selection for biomarker sample analysis and ensure operational feasibility and delivery against contracted scope of work.
• Ensure GCP compliance in biomarker activities.
• Participate in the statistical analysis plan and review of results related to biomarker data.
• Contribute with agility and punctuality to projects and Galapagos’ development needs (e.g. develop work processes).
• The role is based in Basel.
Who are you?
• Strong scientific foundation within academia, including at least 5 years in Clinical research and/or 3 years in Pharmaceutical Industry.
• Relevant experience in the area of Inflammation and Autoimmune diseases or related fields, such as Osteoarthritis, Atopic Dermatitis, Pain, Fibrosis or Metabolism
• Experience working with molecular/immunological techniques, including at least one of the following technologies: immunoassays, transcriptomics, proteomics (eg. LCMS, LBA), metabolomics, histology/immunostaining, microbiomics.
• Clinical drug development or biological laboratory experience, with evidence of involvement in the processing and/or analysis of biological samples and method validation, preferably in a GCP compliance environment.
• Experience in integrating biomarkers into clinical trials is preferable.
• Outstanding communicator with strong interpersonal skills and high ethical standards.
• Strong scientific and analytical skills.
• Decisive and performance driven, whilst working collaboratively.
• Able to prioritize activities.
• Pragmatic ‘can-do’ mindset.
• Fluent in English both spoken and written.
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…!