Elucid · 6 hours ago
Director of Clinical Validation and Evidence
Boston, MA
Full-time
Hybrid
Director/Executive
$195K/yr - $230K/yr
7+ years expElucid is a rapidly growing, Boston-based medical technology company focused on using AI to improve cardiovascular care. They are seeking a Director of Clinical Validation and Evidence to lead clinical quality and validation teams, develop gold-standard reference data, and collaborate across various departments to enhance patient care through innovative technology.
AnalyticsBiotechnologyMedical DevicePrecision Medicine
Responsibilities
Own clinical performance evidence and reference standards for AI-enabled, cardiovascular imaging SaMD products
Shape how the technology is validated, trusted, and adopted
Lead clinical quality and validation teams
Set the bar for gold-standard reference data
Collaborate with engineering, product, research and regulatory partners to turn rigorous science into confident clinical use
Qualification
Required
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
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
Preferred
Advanced degree (Master's or PhD) in biomedical engineering, imaging science, computer science, or a related technical field preferred
Company
Elucid
Elucid enables precision medicine for cardiovascular disease by applying A.I to medical image analysis validated against true biology.
51-200 employees
H1B Sponsorship
Elucid has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (3)
2023 (5)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$166.22MKey Investors
Elevage Medical TechnologiesNational Science Foundation
2025-10-22Series D· $36.5M
2023-11-09Series C· $80M
2022-06-22Series B· $27M
Leadership Team
Kelly Huang
President & CEO, Board Director
Windi Hary
Chief Regulatory and Quality Officer
Recent News
2025-10-30
Medical Product Outsourcing
2025-08-22
Company data provided by crunchbase