Leica Biosystems is looking to accelerate innovation in cancer diagnostics and improve lives by developing diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies.
Requirements
- Experience in AI / ML development for document efficiencies across clinical NPD
- Strong background in NLP and data modeling
- IT skills and experience, particularly in leading the creation, optimization and deployment of AI tools within document generation, review and management
- Experience with AI model validation and explainability (XAI)
- Familiarity with diagnostics, digital pathology, and R&D
- Knowledge of clinical development workflows and associated regulatory and quality processes
Responsibilities
- Lead the development, deployment, and training of GenAI and NLP tools to enhance productivity in documentation processes—covering generation, summarization, classification, and metadata tagging—while ensuring compliance with applicable AI standards
- Ensure AI systems and associated documentation meet all applicable regulatory standards (e.g., FDA, EMA, ISO, GxP, GDPR) by creating and maintaining ISO-compliant SOPs and technical documentation for manufacturing and quality assurance
- Monitor the performance of AI models in real-world diagnostic settings, leveraging feedback and new data to refine and enhance system accuracy and reliability
- Develop and execute post-market evidence strategies that demonstrate the clinical and economic value of AI-enabled diagnostics, supporting broader adoption and regulatory confidence
- Stay current with emerging AI technologies and trends in healthcare and diagnostics, Research and recommend relevant technologies to stakeholders
- Implement and manage AI-powered tools to enable NPD efficiencies, documentation efficiencies, and collaborate with the wider project teams to integrate technologies into document workflows
- Lead validation and audit readiness efforts to support regulatory submissions and reviews
Other
- Degree in Computer Science, Data Science, Biomedical Engineering, or related field
- Travel expectations within this role ~50% (you will need to travel to our UK site with overnight stays)
- Experience of working effectively across functional teams to ensure project timelines are met, driving accountability in others, and working independently with minimal supervision
- Paid time off, medical/dental/vision insurance and 401(k) to eligible employees
- Bonus/incentive pay
