Director of Clinical Validation and Evidence
About The Position
We are 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. Come work at Elucid and be part of delivering on our mission to prevent heart attacks and strokes! At Elucid, we’re using AI to change how cardiovascular disease is understood and treated - and strong clinical evidence is what makes that innovation matter in the real world. We’re looking for a seasoned, hands-on leader to own clinical performance evidence and reference standards for our AI-enabled, cardiovascular imaging SaMD products, shaping how our technology is validated, trusted, and adopted. As Director of Clinical Validation and Evidence, you’ll sit at the intersection of clinical quality, machine learning and imaging science. You'll lead clinical quality and validation teams, set the bar for gold-standard reference data, and collaborate with engineering, product, research and regulatory partners to turn rigorous science into confident clinical use. If you’re excited by building scalable validation and evidence frameworks and having a direct impact on patient care, this is a chance to do exactly that!
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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
101-250 employees
