Senior Specialist, Biomarker

Immunic Therapeutics; Gräfelfing; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Immunic Therapeutics is seeking a motivated team member to support the Biomarker function with a focus on oversight of clinical trial laboratory vendors and biomarker data. The role involves coordinating vendors, preparing scientific outputs, data analysis, and collaboration across cross-functional teams to advance biomarker strategies in regulatory submissions.

The candidate will contribute to literature reviews, analytical insights, and the preparation of scientific materials for internal and

Qualifikationen

• Evaluate scientific literature and generate insights.
• Analyze experimental data and prepare summaries/figures.
• Prepare high-quality scientific outputs for regulatory and internal use.
• Collaborate with clinicians, CROs, labs, and cross-functional teams.

Aufgaben

• Lead operational oversight of laboratory vendors and biomarker labs including sample logistics, timelines, deliverables.
• Coordinate biomarker vendors and external experts, including proposals and timelines.
• Support biomarker strategy, assay feasibility, and internal/KOL discussions.
• Identify novel biomarker opportunities and perform literature reviews.
• Prepare scientific summaries, slide decks, and decision-support materials.
• Support data analysis, interpretation, and figure preparation for reports.
• Collect and organize biomarker data for regulatory submissions and NDA prep.
• Contribute to SOPs and process improvements in cross-functional biomarker discussions.

Kenntnisse

Data analysis

Literature review

Scientific writing

Communication skills

Cross-functional collaboration

Project coordination

Ausbildung

PhD or Master's degree

Tools

R/SAS

Jobbeschreibung

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.