Job Description
Define and execute the AI/ML roadmap aligned to clinical, PV, and quality/audit objectives. Run an AI opportunities and triage process. Establish AI governance: model risk classification, validation/qualification plans, algorithm change control, documentation (model cards, datasheets), and monitoring. Ensure compliance with GxP, 21 CFR Part 11/Annex 11, ICH E6(R3), GVP for PV, data privacy (GDPR/PHI), and vendor and Ergomed IT and security standards. Define and track KPIs. Understands and translates business and functional needs into AI and machine learning problem statements. Designs and develops scalable solutions that leverage machine learning and deep learning models to meet Ergomed business requirements. Works closely with business, process analysts and data engineers to frame business problems and need into AI/ML product or workflow. Oversee design, development, validation, and deployment of ML/NLP/GenAI solutions.
About Ergomed
Ergomed is a rapidly expanding full service mid-sized CRO specializing in Oncology and Rare Disease with operations in Europe, North America and Asia.