Hematology and Safety Biomarker Expert

Hematology and Safety Biomarker Expert

Roche

Basel, Switzerland

The Position

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 responsible laboratory practices.
• Interpersonal skills & Stakeholders & Mentorship: Demonstrate highly collaborative skills across agile, cross-functional project teams within Pharmaceutical Sciences and related institutes, while supervising and training technical staff, apprentices, postdocs, or students.
• Process Optimisation & External Visibility: Continuously optimise laboratory processes to improve quality, efficiency, and sample-handover timelines, while establishing robust networks with Key Opinion Leaders (KOLs) and participating in cross-industry working groups (e.g., FNIH Biomarkers Consortium, PSTC) to track scientific and regulatory trends.

Who you are

• You hold a DVM (with a PhD or relevant specialisation), a PhD in Hematology, Biology, Immunology, Toxicology, or a Master’s degree combined with significant practical experience in in vivo toxicology.
• You bring demonstrated hands-on experience in wet-lab environments, specifically with in vitro and ex vivo safety biomarker assays or clinical pathology data generation (such as hematology, coagulation, clinical chemistry, or urinalysis).
• You possess familiarity with digital data platforms, data curation tools, or automated workflow integrations.
• You have strong communication and relationship-building skills, with an outstanding ability to collaborate effectively across multidisciplinary, global teams.
• You demonstrate a continuous improvement mindset dedicated to optimising laboratory processes and mentoring emerging scientific talent.