Clinical Biomarker Research Manager
3 weken geleden
We are Galapagos, a dynamic and fast-growing Biotech company. As a Clinical Biomarker Leader/Translational Scientist, Associate Director, you will play a key role in the design, analysis, interpretation, and reporting of product characterization and immune monitoring data. You will also establish internal and external assays, including PK/PD/immunogenicity for CAR-T cell clinical trials with internal QC teams and CROs.
Your responsibilities will include:
- Critically assessing, interpreting, and presenting translational data collected during Galapagos' ongoing clinical trials of all phases.
- Co-driving innovation by keeping up-to-date with relevant literature, technology, regulatory guidance, and industry developments.
- Providing CAR-T biology expertise within the company.
- Collaborating with other departments to create synergy in developing biomarker strategies and translational approaches.
- Contributing to product characterization and immune monitoring strategy for clinical studies of all phases and across therapeutic areas.
- Contributing to study documents, such as IND, Clinical Study Reports, and regulatory authority briefing documents.
As a Clinical Biomarker Leader/Translational Scientist, you will contribute directly to the treatment of patients and the generation of data to make CAR-T therapies widely available.
As an experienced professional with a complete understanding of the field of translational research, you will become instrumental in the development of our clinical programs with novel CAR-T therapies in multiple (hemato-)oncological or immunological indications towards clinical trials and regulatory approval.
You will report to the Head of Translational Sciences.
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