Biomarker Operations Jobs in Ohio (NOW HIRING)

CatalYm GmbH

Full-time

88,000 - 100,000 € per year

A central part of our development strategy is to understand which patients benefit most from visugromab, how treatment modulates anti-tumour immunity, and which biomarkers can guide future clinical development. To advance this work, we are seeking a Senior Scientist / Principal Scientist, Clinical Biomarkers to lead the clinical biomarker and translational research programmes across assigned mid-stage oncology trials.

In this role, you will lead the scientific execution and interpretation of the biomarker programmes for your assigned trials, translating complex biomarker, omics, and clinical data into clear conclusions that inform patient selection, clinical development decisions, and our understanding of visugromab’s mechanism of action. This is a scientifically hands-on role that combines independent data analysis and interpretation with cross-functional project leadership and external scientific oversight.

You will be an integral member of the Translational Research & Clinical Biomarkers team and a central contributor to CatalYm’s Research organisation. You will work closely with Clinical Development, Clinical Pharmacology and Bioanalytics, Bioinformatics, Clinical Data Science, Preclinical Research, and Clinical Biomarker Operations, as well as external scientific partners.

The position may be appointed at Senior Scientist or Principal Scientist level, depending on the successful candidate’s experience, demonstrated scientific independence, and previous scope of clinical biomarker programme leadership.

Your responsibilities include:

• Lead the scientific execution, data analysis, and interpretation of the established clinical biomarker programmes across assigned mid-stage oncology trials.
• Oversee biomarker data generation and critically evaluate assay performance, analytical methods, data quality, and scientific deliverables from CROs, specialty laboratories, and external collaborators.
• Lead the statistical, exploratory, and integrated analysis of complex biomarker, omics, and clinical datasets across assigned trials, including gene-expression profiling, proteomics, ctDNA, and other relevant approaches. Translate findings into conclusions that inform the understanding of visugromab’s mechanism of action, responder profiles, patient selection, and biomarker strategy.
• Independently identify and lead translational research projects arising from clinical and biomarker findings, and proactively contribute new hypotheses and scientific opportunities to CatalYm’s broader translational research direction.
• Work closely with Bioinformatics, Biostatistics, and Clinical Data Science on complex analyses while retaining scientific ownership of the questions, interpretation, and conclusions.
• Provide scientific direction to external laboratories and collaborators in close partnership with the Clinical Biomarker Operations Specialist, who coordinates vendor selection and leads contracting, logistics, and operational management.
• Contribute to budget planning and forecasting for assigned biomarker and translational research activities and maintain responsibility for tracking scientific scope, timelines, risks, deliverables, and external spend.
• Author and provide scientific review of biomarker-related content for clinical study protocols, laboratory manuals, statistical analysis plans, validation reports, and regulatory documents.
• Present biomarker and translational findings to internal and external stakeholders and drive scientific publications and conference presentations.
• Ensure appropriate data governance, quality, integrity, and traceability across biomarker and translational datasets.
• Provide biomarker expertise to Clinical Pharmacology and Bioanalytics and other cross-functional teams as required.

Who you are:

• Ph.D. in immunology, molecular biology, cancer biology, biochemistry, bioinformatics, bioanalytical chemistry, or a related life-science discipline.
• At least five years of relevant biotechnology or pharmaceutical industry experience in clinical biomarkers, translational medicine, or translational research.
• A track record of leading clinical biomarker activities or programmes and translational research projects in oncology trials, with a demonstrated ability to operate independently.
• Deep expertise in translational science and/or immuno-oncology, including biomarker discovery, mechanism-of-action studies, responder profiling, and patient stratification.
• Demonstrated ability to analyse and integrate complex biomarker, omics, and clinical datasets and translate findings into biomarker strategies and recommendations for clinical development.
• Hands‑on experience with high‑dimensional biomarker or omics data and relevant analysis and visualisation tools; proficiency in R or Python is a strong advantage.
• Experience providing scientific direction to CROs, specialty laboratories, academic collaborators, and other external partners, including contributions to vendor selection and oversight of budgets, timelines, risks, and deliverables.
• Working knowledge of fit‑for‑purpose biomarker assay development and validation, GCP requirements, and regulatory expectations for biomarkers in clinical development.
• Strong scientific leadership, communication, and cross‑functional collaboration skills, supported by a track record of peer‑reviewed publications and presentations to internal and external stakeholders.

• A scientific leadership role at the interface of translational research, clinical biomarkers, and clinical development.
• The opportunity to shape the development of an innovative cancer therapy and lay the scientific foundation for a potential first‑in‑class treatment.
• A collaborative and purpose‑driven team environment.
• Flexible working arrangements that combine regular weekly on‑site collaboration with the option to work remotely on selected days.
• A permanent employment contract with competitive compensation and attractive employee benefits.

CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti‑tumor efficacy with long‑lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti‑PD‑1 treatment. Our mission is to rapidly bring our next‑generation immuno‑oncology products to patients in need. Are you ready to board the fast‑accelerating visugromab train in Martinsried? Then join us!