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Welcome to Galapagos, a vibrant and rapidly expanding Biotech organization with a presence across Europe and a headquarters in Belgium (Mechelen).

Our mission is to transform lives through the discovery and development of innovative medicines. We embrace challenges as opportunities and seek to redefine the boundaries of possibility. We are in search of visionary thinkers, entrepreneurial spirits, and collaborative innovators who are ready to tackle the status quo. We need exceptional talent. In essence, we need you: the 'make-it-happeners'.

We are currently seeking a Clinical Biomarker Leader/Translational Scientist, Associate Director to enhance our capabilities in any Galapagos location.

Job Scope

As a Clinical Biomarker Leader / Translational Scientist, you will be an integral part of Galapagos' Translational Science team located in the Leiden Bio Science Park. Your expertise will be crucial in the design, analysis, interpretation, and reporting of data related to product characterization and immune monitoring. Additionally, you will be responsible for establishing both internal and external assays, including PK/PD/immunogenicity for CAR-T cell clinical trials, collaborating closely with our internal QC team and external CROs. You will work in close partnership with Clinical Development, Process Development, Analytical Development, and other stakeholders to ensure the collection of relevant data.

As a seasoned professional with comprehensive knowledge in translational research, you will play a pivotal role in advancing our clinical programs involving novel CAR-T therapies across various (hemato-)oncological and immunological indications, steering them towards clinical trials and regulatory approval. Your contributions will directly impact patient treatment and facilitate the generation of data necessary for the widespread availability of these CAR-T therapies.

The Clinical Biomarker Leader / Translational Scientist will report directly to the Head of Translational Sciences.

Key Responsibilities

Thoroughly evaluate, interpret, and present translational data gathered during Galapagos' clinical trials across all phases. Drive innovation by staying informed on relevant literature, technological advancements, regulatory guidelines, and industry trends. Provide expertise in CAR-T biology within the organization. Collaborate with various departments to foster synergy in developing biomarker strategies and translational methodologies. Contribute to the product characterization and immune monitoring strategy for clinical studies across all phases and therapeutic areas. Assist in the preparation of study documents, including IND submissions, Clinical Study Reports, and regulatory authority briefing materials.