Head of Clinical Validation and Evidence

Head of Clinical Validation and Evidence at a rapidly growing, Boston-based medical technology company using AI to enable clinicians to make informed decisions on cardiovascular care, leading to better patient outcomes, improved quality of care, and reduced healthcare costs.

Requirements

• 7-10+ years of experience in clinical quality, medical imaging or software-as-a-medical-device (SaMD) validation, including 5+ years leading clinical quality or validation teams
• Advanced degree (Master’s or PhD) in biomedical engineering, imaging science, computer science, or a related technical field preferred
• Hands-on experience with medical imaging and AI-enabled products, including AI training datasets, quantitative imaging biomarkers, or advanced imaging domains (e.g., CT, FFRct, plaque analysis)
• Proven expertise designing and executing clinical comparison studies, performance metrics, and statistical analyses within regulated environments (FDA, MDR, ISO 13485)
• Strong working knowledge of software design controls and agile software development life cycle (SDLC) in a regulated SaMD context
• Demonstrated ability to lead, mentor, and scale high-performing, multidisciplinary teams while navigating ambiguity and complexity
• Excellent communication and collaboration skills, with a track record of partnering across engineering, product, research, regulatory teams, and external clinical experts or Key Opinion Leaders

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Health Insurance
• Dental Insurance
• Vision Insurance