Medical Director, Cardiac Imaging

Role Summary

Medical Director, Cardiac Imaging

The Director will provide medical affairs expertise in the development of cardiac imaging for structural heart diseases, shape the medical direction of NuVision 4D ICE Technology, ensure regulatory compliance, and collaborate with R&D, Clinical Research, and marketing teams to support product development, approvals, and adoption.

Responsibilities

• Lead the support for all clinical studies for regulatory purposes and physician-initiated collaborative studies, including case support, training, data analysis, and publication support.
• Develop and execute evidence generation and dissemination strategies for company-sponsored and investigator-initiated research.
• Collaborate with Preclinical and Clinical Research teams to develop global evidence-generation strategies supporting regulatory approval, HTA, access, and post-marketing support.
• Provide scientific oversight for clinical trial concept, design, analysis, and reporting; develop study materials (investigator brochures, training materials).
• Coordinate with Medical Safety to review and escalate adverse events from clinical studies as needed.
• Contribute scientific input to the analysis of study results and prepare reports for regulatory submission or publication.
• Ensure medical content accuracy in internal product documentation and regulatory submissions.
• Safeguard patient safety; approve Design History Files, Technical Guides, and Clinical Evaluation Reports as part of product dossiers.
• Review and approve educational, promotional, and reporting materials; prioritize publication proposals with Clinical Science.

Cross Function Collaborations

• Collaborate with R&D, Clinical Research, Business Development, Regulatory Affairs, Quality & Compliance, Health Economics & Market Access, and Professional Medical Education to influence regulatory and commercial strategy and support product development and launches.
• Participate in governance forums and leadership teams; support site activation, physician training, and gather feedback on product performance.
• Provide medical and scientific insights to Marketing, R&D, Communications, Legal, Quality Assurance/Risk Management, and Commercial teams.

External Engagements

• Engage Key Opinion Leaders, Professional Societies, payers, and providers to understand care trends and insights for product innovation.
• Develop relationships with academic leaders researching Cardiac Imaging; collaborate with functions interacting with Cardiac Imaging customers.
• Willingness to travel up to 35% of the time.

Program Oversight and Team Development

• Align strategy, budget, and resources with cross-functional partners.
• Recruit, mentor, and develop the Cardiac Imaging Medical Affairs team.
• Ensure compliance with health, safety, environmental practices and regulatory requirements.

Qualifications

• A degree in medicine (MD, DO, etc.) with training in Cardiology is required.
• Minimum 10 years of relevant experience in Cardiac Imaging-related studies (Cardiac Imaging, Echocardiography, Structural Heart Imaging).
• Experience in product development for Cardiac imaging; Structural Heart imaging is highly desired.
• Strong cardiovascular domain knowledge; proven ability to learn complex technology/clinical applications.
• Significant clinical research experience; prior leadership and people-management experience.
• Excellent communication and negotiation skills; ability to influence in a matrix environment.
• Experience leading Medical/Clinical teams in regulated biomedical or medical device environments preferred; experience with risk evaluation and mitigation is a plus.
• Demonstrated success in medical data generation, interpretation, and publications is highly preferred.
• Willingness to travel approximately 35% domestically and internationally.

Education

• A degree in medicine (MD, DO, etc.) with training in Cardiology is required.