Biomarker Scientist

Biomarker Scientist

argenx

Ghent, Belgium

For the expansion of the Translational Science team, argenx is actively looking for a highly motivated Biomarker Scientist with expertise in immunology research. As a Biomarker Scientist you take on a key role in supporting biomarker strategies to enable stratified medicine/diagnostic approaches (where appropriate), and overall to enhance the probability of successful drug development and approval. You will support the discovery and implementation of disease-specific biomarkers and biomarkers for patient selection. You will work in close collaboration with internal and external project teams. We are specifically looking for a polyvalent scientist keen to work on different projects, with knowledge on the selection, development, analytical validation and outsourcing of clinically applicable biomarker assays.

Main roles & responsibilities

• Participate in the selection of biomarkers to measure predictive, pharmacodynamic and safety biomarkers, including biomarkers supporting treatment response, disease understanding and Mode-of Action;
• Translate the biomarker context of use (COU) into analytical requirements and ensure fit-for-purpose assay and vendor selection;
• Drive the implementation of biomarker assays, including assay development and validation, as well as biomarker sample analysis, both internally and/or in collaboration with external vendors or academic collaborators;
• Act as a subject matter expert in ligand binding assay biomarker technologies, and their development and implementation in clinical programs;
• Support data analysis in line with COU and clinical development strategy;
• Work across projects to assure harmonization of biomarker assay implementation and data interpretation;
• Review and provide input in clinical trial documents (protocols, reports, DTAs, lab manuals, ICFs), and contribute in interactions with regulatory agencies;
• Contribute to the growth and further development of the Translational Science team.

Professional experience/expertise

• PhD in Immunology or Molecular Biology with at least 3 years of relevant research/industry experience, or Master’s degree with extensive industry experience in analyzing human samples and/or monitoring analysis of biomarkers during clinical trials;
• Pharma/Biotech experience in the development & implementation of biomarker strategies and methods to support drug development;
• Proven track record/publications in innovative science/pathobiology;
• Experience of disease areas/conditions aligned to argenx’s core immunology-focused ambitions;
• Direct experience with the characterization of biomarkers using ligand binding assays; experience with other analytical platforms such as flow cytometry, proteomics, molecular biology and/or immunohistochemistry is considered a plus;
• Understanding of concepts such as COU and and fit-for-purpose biomarker assay validation and how to apply these;
• Experience in implementing biomarker assays (development and validation) in clinical studies and analysing corresponding data;
• Experience in managing outsourced activities at external vendors;
• Understanding of GCP/GCLP guidelines and current global regulations.

Profile

• Profound medical/scientific knowledge, especially in the fields of immunology;
• Resilience with the ability to adapt to changes in priorities and to work effectively on multiple programs in a fast-paced environment;
• Motivated, enthusiastic, accurate in execution and reporting;
• Strong project, organization, and interpersonal skills;
• Good communication skills and good written and oral English language skills;
• Team-player, capable to collaborate effectively with internal and external stakeholders.