Medical Director, Cardiac Imaging

Role Summary

The Medical Director, Cardiac Imaging leads medical affairs for cardiac imaging in structural heart diseases, shaping the medical direction of NuVision 4D ICE Technology, ensuring regulatory compliance, and driving clinical innovation. This role provides strategic input on long-term product opportunities and portfolio strategies, supports evidence generation for approvals and claims, collaborates with R&D, Clinical Research, marketing, and commercial teams, and builds relationships with key external stakeholders to anticipate industry trends and unmet needs.

Responsibilities

• Lead support for all clinical studies for regulatory purposes and physician-initiated collaborative studies, including case support plans, physician training, data analysis, publication support, and data collection for platform claims.
• Contribute to development and execution of 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 to support regulatory approval/clearance, HTA, customer access, and post-marketing support.
• Provide scientific oversight for clinical trial concept, design, analysis, and reporting; develop materials used in study execution.
• Work with Medical Safety to review, trend, and escalate adverse events from clinical studies; provide scientific input on study results.
• Assist in preparing reports on clinical investigations for regulatory submission or publication to meet evidence requirements; ensure medical content of internal 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 publications in collaboration 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, studies, safety, and launches.
• Participate in governance forums (Business Unit leadership, cross-functional product core teams, EGS teams, portfolio/strategy management, Safety and Quality Review Boards).
• Support commercial launches by activating sites, providing physician training, and collecting feedback on product performance.
• Provide medical and scientific insights to Marketing, R&D, Communications, Legal, Quality Assurance/Risk Management, and Commercial teams to guide strategic direction and tactical activities.

External Engagements

• Engage Key Opinion Leaders, Professional Societies, Payers and Providers to understand care trends and uncover insights for product innovation.
• Develop relationships with academic leaders researching Cardiac Imaging; collaborate with functions engaging Cardiac Imaging customers/physicians.
• Ability and 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 support professional growth of the Cardiac Imaging Medical Affairs team.
• Ensure compliance with Health, Safety and Environmental practices and regulations; ensure necessary resources are available.

Education

• A doctorate degree in medicine or medical science (MD, DO, PhD, etc.) is required.

Experience And Skills

• Minimum 10 years of relevant experience in Cardiac Imaging, Echocardiography, or Structural Heart Imaging.
• Experience in product development for Cardiac Imaging; familiarity with Structural Heart imaging is highly desired.
• Strong cardiovascular and cardiac imaging knowledge; ability to learn complex technology and clinical applications.
• Significant experience with clinical research; proven leadership and ability to build global partnerships.
• Prior people management experience; ability to work in a matrix environment and influence policy with key customers.
• Experience leading Medical/Clinical teams in regulated biomedical or medical device environments; knowledge of risk evaluation and mitigation is preferred.
• Experience in medical data generation, interpretation, and publications is highly preferred.
• Willingness and ability to travel approximately 35% domestically and internationally.

Additional Requirements

• Travel: up to 35% travel required.