argenx is actively seeking a highly motivated Biomarker Lead (senior/principal scientist level) with expertise in immunology research to expand its Translational Science team. The Biomarker Lead will play a crucial role in supporting biomarker strategies to enable stratified medicine/diagnostic approaches (where appropriate) and enhance the likelihood of successful drug development and approval. The chosen candidate will assist in discovering and implementing disease-specific biomarkers and biomarkers for patient selection, collaborating closely with internal and external project teams. We are specifically seeking a versatile scientist eager to contribute to various projects, possessing knowledge of selecting, developing, analytically validating, and outsourcing clinically applicable biomarker assays.

Main roles & responsibilities :
• Actively engage in developing biomarker and precision medicine strategies by collaborating closely with cross-functional team members and serving as a pivotal member of biomarker subteams.

• Participate in selecting biomarkers for predictive, pharmacodynamic, and safety assessments, including those supporting treatment response, understanding disease, and Mode-of-Action.

• Translate the context of biomarker use (COU) into analytical requirements to ensure the suitability of biomarker assays and appropriate vendor selection.

• Lead the implementation of biomarker assays, encompassing development, validation, and sample analysis, either internally or in collaboration with external vendors or academic partners.

• Serve as an expert in various biomarker technologies, both established and cutting-edge, guiding their development and integration into clinical programs.

• Conduct data analysis aligned with COU and clinical development strategies.

• Collaborate across projects to ensure consistency in biomarker assay implementation and data interpretation.

• Review and contribute to clinical trial documents (protocols, reports, DTAs, lab manuals, ICFs), and participate in interactions with regulatory agencies.

• Assist in establishing a preferred vendor base for biomarkers.

• Contribute to the growth and advancement of the Translational Science team.

Professional experience / expertise :

• PhD in Immunology or Molecular Biology, coupled with a minimum of 6 years of relevant industry research experience, or Master's degree with extensive industry expertise in analyzing human samples and/or overseeing biomarker analysis in clinical trials.

• Previous experience in Pharma/Biotech, specifically in crafting and executing biomarker strategies and methodologies to bolster drug development efforts.

• Demonstrated track record and publications showcasing innovative scientific contributions and pathobiology insights.

• Familiarity with disease areas and conditions aligned with argenx's core focus on immunology.

• Hands-on experience in biomarker characterization using techniques such as flow cytometry, proteomics, molecular biology, and immunohistochemistry.

• Proficiency in understanding concepts like Context of Use (COU) and the validation of fit-for-purpose biomarker assays, and ability to apply these concepts effectively.

• Proven experience in implementing biomarker assays (both development and validation) in clinical studies, along with proficiency in analyzing associated data.

• Experience in overseeing outsourced activities at external vendors.

• Familiarity with Good Clinical Practice (GCP)/Good Clinical Laboratory Practice (GCLP) guidelines and current global regulations.

Profile:

• Extensive medical and scientific expertise, particularly in immunology.

• Collaborative, motivated, and enthusiastic, with a commitment to precision in execution and reporting.

• Robust project management, organizational, and interpersonal abilities.

• Effective communication skills, both written and verbal, in English.

• Resilience and adaptability to shifting priorities, capable of managing multiple projects in a dynamic setting.

• A team player, adept at fostering effective collaboration with internal and external partners.

Offer:

• Full-time role within a collaborative, vibrant, and expanding organization.

• Collaborate within a cross-functional team, accessing a wide range of cutting-edge technologies.

• Chance to play a significant role in expanding the Translational Science team.

• Competitive salary package with comprehensive benefits, tailored to experience level.

• Option for part-time remote work with minimal travel obligations.

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