Clinical Development Scientist
Core
Owns end-to-end clinical evidence strategy and leads clinical development for AI-based ultrasound medical devices, linking clinical need to regulatory acceptance and post-market requirements.
Role type
Senior Clinical Development Scientist (AI Medical Devices)
Builds
Clinical evidence strategies, study protocols, and regulatory submissions for AI ultrasound features
Domain
MedTech, Diagnostic Radiology/Ultrasound, AI Medical Devices
Deliverable
production ML models (clinical validation & evidence generation)
Required skills
Clinical development strategy, Clinical study design, Protocol development, Clinical evidence generation, Regulatory compliance (MDR/510k), Medical writing (CER/CSR), Real-world data analytics, Cross-functional leadership
Preferred skills
Medical writing, Scientific publications, Data analysis (R, Python), Project management
Technologies
R, Python, Power BI, Tableau, Git, ADO/Azure
Responsibilities
Define clinical evidence strategy and TPP, Lead clinical study design and execution, Manage site/KOL engagement, Oversee data strategy and integrity, Operationalize real-world data for PMCF, Author regulatory documents (CER, CSR, 510k)
Seniority
Senior, hands-on IC with strategic oversight