Biomarker Lead

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.
- 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 mínimal travel obligations.

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