Clinical Biomarker Leader/Translational Scientist, Associate Director

2 maanden geleden

Leiden, Nederland Galapagos Voltijd

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices across Europe and headquartered in Belgium (Mechelen) .

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: The ‘make-it-happeners’.

We are looking for a Clinical Biomarker Leader/Translational Scientist, Associate Director  to join our team in Any Galapagos location.

Scope of the job

As a Clinical Biomarker Leader / Translational Scientist you join Galapagos’ Translational Science team in the Leiden Bio Science Park. You play a key role in the design, analysis, interpretation and reporting of product characterization and immune monitoring data. Furthermore, you will be establishing internal and external assays including PK/PD/immunogenicity for CAR-T cell clinical trials with internal QC team as well as CROs. You enjoy working in close collaboration with Clinical Development, Process Development, Analytical Development and other stakeholders to ensure relevant data are collected.

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. By doing so, you contribute directly to the treatment of patients, and the generation of data to make these CAR-Ts widely available.

The Clinical Biomarker Leader / Translational Scientist reports to the Head of Translational Sciences.

Your role

Critically assess, interpret and present translational data collected during Galapagos’ ongoing clinical trials of all phases Co-drive innovation by keeping up-to-date with relevant literature, technology, regulatory guidance and industry developments Providing CAR-T biology expertise within the company Collaborate with other departments to create synergy in developing biomarker strategies and translational approaches Contribute to product characterization and immune monitoring strategy for clinical studies of all phases and across therapeutic areas Contribute to study documents, such as IND, Clinical Study Reports and regulatory authority briefing documents

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