Job Summary

A rapidly growing medical device company is preparing to enter the North American market with a groundbreaking, FDA-designated breakthrough technology aimed at transforming the standard of care in cardiac surgery. We are seeking an experienced life sciences physician to lead the management and execution of medical, scientific, and clinical initiatives across North America. This individual will play a critical role in shaping the medical vision and strategy, building the regional medical affairs team, and serving as a key member of the executive leadership.

We are looking for candidates with deep cardiovascular expertise and a proven track record in the field. Ideal candidates will bring an open mindset, entrepreneurial approach, strong problem-solving abilities, and a high level of professional integrity and drive.

Responsibilities

• Responsible for the development of the MA strategy, tactical plan, and associated budget
• Responsible for the management and execution of the MA plan, including:
  • Medical conferences
  • Scientific advisory boards (national and regional)
  • Educational activities
    • Internal: Commercial team training
    • External: CME/non-CME programs; webinars
      • Centers of excellence program
      • Peer-to-peer program
      • Real-world evidence generation
        • Post-marketing studies
        • Health economic analyses
          • Publication strategy
            
• Responsible for post-market surveillance in collaboration with quality department
• Responsible for internal and external communications and progress updates of MA activities
• Close collaboration with Scientific Advisory Board members and KOL network
• Coordination and collaboration with marketing and commercial teams to maximize reach and effectiveness of MA activities
• Involved in the development of the strategy for ongoing evidence generation and regulatory filings for label expansions
• Responsible for the design, medical oversight and execution of ongoing clinical studies in North America in close collaboration with clinical operations
• Ability for significant travel that is estimated at approximately 50% of time
  

Qualifications

• MD, MD/PhD degree with specialty training in cardiovascular disease (cardiology, interventional cardiology, cardiac surgery, vascular surgery) and at least 10 years of professional experience
• Previous industry experience in drug or device clinical development and medical affairs preferred, but candidates from academia maybe considered based on track record of successful clinical investigation and academic productivity (clinical studies, publications)
• Track record in designing, executing, analyzing and reporting/publishing rigorous clinical studies. Experience with regulatory filings and presentations to FDA or other regulatory authorities desired but not required
• Significant experience in data collection and analysis, statistics and presentation of study results
• Existing vast institutional and KOL network in the CV space with demonstrated track record of successful collaboration with top academic leaders and institutions
• Experience in the creation, execution and participation in scientific advisory boards
• Polished academic skills including ability to create high quality educational materials and deliver credible presentations at top-tier scientific venues and ability to draft manuscripts for top peer reviewed journals
• Previous experience in supporting the launch of newly approved drugs or devices in the CV space highly desirable but not required
• Understanding of regulations and compliance requirements relevant to medical affairs activities and workstreams
• Understanding of evolving market dynamics and experience engaging with all key stakeholders (hospitals, VAC and P&T committees, hospital systems, IDNs, payers, etc.)
• Proven track record of the ability to strategize, prioritize and manage multiple projects simultaneously while ensuring they are completed with the highest quality
• Strong executional focus with ability to develop/improve processes to ensure timely execution
• Managerial experience in leading teams to successful execution based on meticulous project management and tactical | operational oversight.
• Ability to leverage medical expertise to guide multidisciplinary and cross-functional teams
• Track record of effective and successful cross departmental collaboration