Biomarker Scientist

argenx

Ghent, Belgium

To support the growth of our Translational Science Biomarker Team, argenx is seeking a highly motivated biomarker scientist with a strong background in immunology research. This pivotal role will focus on developing biomarker strategies that facilitate stratified medicine and diagnostic approaches, ultimately enhancing the likelihood of successful drug development and regulatory approval. The selected candidate will play a critical role in the implementation of disease-specific biomarkers and biomarkers for patient selection. Collaboration will be essential, as the scientist will work closely with both internal and external project teams. We are particularly looking for a versatile scientist who is eager to engage in a variety of projects and possesses expertise in the selection, development, analytical validation, and outsourcing of clinically applicable biomarker assays.

Main roles & responsibilities

Act as a member of biomarker sub teams to support biomarker strategy establishment by providing insight into assay technical feasibility;
Responsible for the translation of the biomarker context of use (COU) into analytical requirements to ensure the use of fit-for-purpose biomarker assays and appropriate 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;
Serve as a subject matter expert in ligand binding assays, focusing on their implementation in clinical programs, and the establishment of standardized best practices;
Contribute to the data analysis in line with COU and clinical development strategy;
Work across projects to assure harmonization of biomarker assay implementation and data interpretation;
Review of clinical trial related documents (protocol, data transfer agreement, lab manual…), as well as regulatory documents;
Support the establishment of a preferred biomarker vendor base;
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 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;
Direct experience with the characterization of biomarkers using ligand binding assays;
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 analyzing corresponding data;
Experience in managing outsourced activities at external vendors;
Understanding of GCP/GCLP guidelines and current global regulations.

Profile

Team player, motivated, enthusiastic, accurate in execution and reporting;
Strong project, organization, and interpersonal skills;
Good communication skills and good written and oral English language skills;
Resilience with the ability to adapt to changes in priorities and to work effectively on multiple programs in a fast-paced environment;
Team-player, capable to collaborate effectively with internal and external stakeholders.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job