Software Clinical Research Manager
Core
Define and own clinical evidence strategy for new and updated AI and machine learning algorithms within software-based digital dentistry solutions.
Role type
Senior IC clinical research manager (AI/ML medical software)
Builds
Clinical evidence roadmaps, validation studies, and regulatory substantiation for AI algorithms
Domain
Digital dentistry + AI/ML medical software
Deliverable
production ML models
Required skills
Clinical evidence generation, AI validation principles, regulatory expectations, scientific literature synthesis, clinical data governance, project management
Preferred skills
Mentoring clinical project roles, cross-functional collaboration
Technologies
FDA 510(k) clearances, clinical validation study methodologies
Responsibilities
Evaluate clinical intended use and accuracy acceptance criteria for AI algorithms, define clinical evidence roadmaps and validation studies, own clinical data governance across research and regulatory use, partner with validation and regulatory teams to design clinically meaningful studies, act as escalation point for data quality and regulatory alignment risks
Seniority
Senior, hands-on IC