Director of Clinical Validation and Evidence
- 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.
- This is a role based out of our office in Boston, MA. Our team is hybrid and has a preference for local candidates or those located in eastern time zones in the continental U.S.
- The anticipated base salary range for this position at Elucid is $195,000-$230,000. Compensation will be influenced by a wide array of factors including but not limited to internal pay equity, job-related knowledge, skills, education, relevant experience, certifications, and geography as outlined in the job description.
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At Elucid, we believe the best work happens in a flexible hybrid environment. Boston-area employees are encouraged to work from the office on Mondays and Wednesdays, with the option to come in additional days if they prefer. Fully remote employees outside the Boston area come in as needed.
We are an equal opportunity employer and value diversity at Elucid. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability.
We understand that self-doubt can sometimes prevent great candidates from applying. If you believe you can make an impact at Elucid, even if you don’t meet every qualification, we encourage you to apply!
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