Biomarker Scientist

argenx is a fast-growing clinical-stage biopharmaceutical company developing innovative potential therapies to help improve the lives of people suffering from severe autoimmune diseases. Our global team is committed to living by our values of collaboration, empowerment, humility, innovation and excellence. As we continue to expand our therapeutic franchises, spanning neuromuscular, hematology, dermatology and nephrology, we remain science-based, data-driven and patient-focused.

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
- 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
- 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

Offer:

- Full time position in a collegial, dynamic and growing company
- Work in a cross-functional team with access a broad array of technologies
- Opportunity to contribute to the continued build out of the Translational Science team
- A competitive salary package with extensive benefits
- Possibility to work remotely in combination with regularly scheduled working days onsite in Zwijnaarde (Ghent)

LI-onsite