Hematology and Safety Biomarker Expert — Roche

Full description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position In Roche’s Pharmaceutical Research and Early Development organisation (pRED), we make transformative medicines for patients to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. Together, we create a culture defined by curiosity, responsibility, and humility, where our talented people are empowered and inspired to bring forward extraordinary, life-changing innovation at speed.

At the intersection of science and innovation, pRED’s Pharmaceutical Sciences (PS) organisation enables the discovery and development of safe and effective therapeutics at optimal doses in relevant populations with a vision to power translation, continuously improve the accuracy of our predictions and accelerate the development of tomorrow's medicines. By seamlessly integrating our three core pillars—Translational Safety, Translational Pharmacology, and Biomarkers—we drive end-to-end asset development across the entire value chain, from target assessment to on-market support. Our mission is to continuously improve predictive accuracy, optimise dosing strategies for the right patient populations, and accelerate the development of tomorrow's safe and effective therapeutics.

This position is located in Pathology and Applied Safety Science, a department within the Pharmaceutical Sciences function. We drive the non-clinical safety assessment of drug candidates from small molecules to complex biological products during the discovery and development phases at Roche.

The Opportunity

As an engaged Pathology and Applied Safety Science Hematology & Safety Biomarker Expert, you will play a pivotal role in the development, validation, and implementation of assays for translational safety assessment. Your primary responsibility will be to propose, conduct and report relevant assays to understand mechanisms of toxicity, leveraging modern tools to maximise scientific insights, drive innovation, and advance our therapeutic pipeline in a highly collaborative environment.

• Strategic Biomarker Integration & Translational Safety: Collaborate with experts to develop and execute integrated in vitro and in vivo hematology and safety biomarker strategies, provide subject matter expertise for clinical candidate selection, and deliver comprehensive safety risk assessments for regulatory documentation (e.g., IND/CTA).
• Multi-Disciplinary Laboratory Expertise: Allocate approximately 50% of working time to wet-lab work, focusing on the development and implementation of tailored in vitro and ex vivo hematology and fluid-based safety biomarker assays, as well as generating and compiling clinical pathology data (hematology, coagulation, clinical chemistry, urinalysis) for the responsible pathologist.
• Digitisation, Image Analysis, and Automation: Partner with Digital Pathology and modelling experts to develop screening assays, utilise digital and data curation platforms (e.g., LIMS, SLIMS, Arvados) to ensure streamlined data transfer and harmonised datasets, and optimise workflow integration to maximise operational efficiency.
• Vendor Management, Quality, & Compliance Outsourcing & CRO Coordination: Manage external partnerships and drive the outsourcing of relevant assays to contract research laboratories (CROs), ensuring strict adherence to timelines and data quality standards.
• Safety Standards: Maintain strict compliance with Safety, Health, and Environmental (SHE) regulations, actively fostering a culture of safe and res