Senior Specialist, Biomarker in Gräfelfing

We are seeking a motivated team member to support the Biomarker function, with a primary focus on operational oversight of clinical trial laboratory vendors and specialty labs. The role combines vendor coordination, sample logistics, data analysis, biomarker strategy support, preparation of scientific and regulatory-relevant outputs, and close collaboration in a cross-functional environment.

Responsibilities:

• Lead operational oversight of clinical trial laboratory vendors and specialty labs, including sample logistics, timelines, deliverables, issue resolution, and clinical team communication.
• Coordinate biomarker vendors, CROs, and external experts, including proposals, specifications, timelines, and deliverables.
• Support biomarker strategy, assay feasibility assessment, and preparation for internal and KOL discussions.
• Identify and evaluate emerging or novel biomarker candidates, including independent scientific exploration beyond established approaches.
• Perform literature reviews and prepare scientific summaries, slide decks, and decision-support materials.
• Support data analysis, interpretation, figure preparation, and scientific report writing.
• Collect and organize biomarker data and documentation for regulatory submissions and NDA preparation.
• Contribute to SOPs, work instructions, process improvements, and cross-functional biomarker discussions.

Qualifications & Education:

• Advanced degree (PhD or Masters) with relevant pharmaceutical or biotechnology industry experience.
• Strong understanding of biological mechanisms, translational research, clinical trial design, and clinical development processes.
• Knowledge of Good Clinical Practice (GCP), clinical trial documentation standards, and regulatory requirements; familiarity with FDA/EMA expectations is an advantage.
• Ability to evaluate scientific literature, analyze experimental data, and generate meaningful scientific insights.
• Experience with preparing high-quality scientific summaries, presentations, figures, graphs, and tables; working knowledge of statistical concepts.
• Strong communication skills with the ability to collaborate effectively with clinicians, external experts, CROs, laboratories, and cross-functional teams.
• Highly organized, proactive, and capable of managing multiple priorities while maintaining accuracy and meeting timelines.
• Analytical mindset driven by curiosity, with the ability to identify innovative biomarker opportunities and solutions.

Immunic Therapeutics is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.