Clinical Development Scientist
Core
Owns end-to-end clinical evidence strategy, study design, and real-world data analytics for AI-based medical devices in radiology/ultrasound to ensure regulatory acceptance and post-market safety.
Role type
Senior Clinical Development Scientist (AI/MedTech)
Builds
Clinical evidence packages, regulatory submissions (510k, Technical Documentation), and post-market surveillance reports for ultrasound imaging devices.
Domain
MedTech / Healthcare / AI in Radiology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study design, protocol development, real-world data integration, regulatory compliance, clinical evidence generation strategy, project management, data analysis, medical writing
Preferred skills
Regulatory Compliance, Clinical Evaluation and PMCF methodologies, Medical and Regulatory Writing, Data Analysis and Interpretation, Quantitative and Real-World Evidence Methods, Strategic Planning, KPI and Performance Management
Technologies
R, Python, Power BI, Tableau, Git, ADO, Azure
Responsibilities
Define clinical evidence strategy linking clinical need to regulatory acceptance; lead clinical study design and execution; manage site/KOL engagement and protocol adherence; oversee data strategy and real-world data integration; author clinical and regulatory documents; drive post-market evidence surveillance and claims validation; manage program risk and cross-functional alignment.
Seniority
Senior, hands-on IC
