Head of Medical Affairs, Structural Heart

About the position

Johnson and Johnson is currently seeking a Head of Medical Affairs, Structural Heart located in Santa Clara, CA or remote for the ideal candidate in the United States. The Head of Medical Affairs, Structural Heart will oversee the Pre-Clinical, Field Clinical and Post-Market Commercial Products teams under Medical Affairs. This position is responsible for developing and executing the vision, mission and goals for the Medical Office, in alignment with the company's business strategy. This position will play a pivotal role in shaping the medical direction of our Ultrasound imaging and Left Atrial Appendage Elimination (LAAE) Platform Technologies, ensuring compliance with regulatory standards and driving innovation in medical technology development. This role will provide medical and scientific leadership expertise in the area of Ultrasound imaging and LAAE and the management of patients in related clinical disciplines. The successful candidate will report directly to the VP of Scientific Affairs and will work closely with cross-functional teams to develop strategy and achieve business objectives.

Responsibilities

• Oversight of Pre-Clinical, Field Clinical; and Post-Market Evaluation for Structural Heart
• Provide deep surgical insights, gather, assimilate, and translate opportunities to address unmet surgical needs to inform the Franchise innovation agenda
• Responsible for building our Global Field Clinical team with training assets and proctor program
• Provides medical input into Target Product Profile
• Risk management and safety oversight across end-to-end processes, including medical input into adverse event reporting, complaints, Health Hazard Evaluations, Field Action Committee and Complaint Review Board
• Ability to provide independent, medical input to critically evaluate clinical risk, and make evidence-based risk benefit determinations / assessments
• Lead medical input into critical business decisions regarding potential patient safety issues
• Analysis and interpretation of signals and trends from multiple inputs including clinical data, literature, complaints, etc.
• Oversee the Pre-Clinical, Field Clinical and Post-Market launch organizations for Medical Affairs
• Responsible for managing operational aspects of their teams (e.g., budget, performance, and compliance)
• Implement workforce and succession plans to meet business needs
• Bring and develop strong relationships with the top academic clinical physician leaders in the field of Left Atrial Appendage and related clinical fields
• Develop and sustain strong relationships with senior leaders at the FDA
• Reviews and approve key regulatory submissions and communications with the FDA and other regulators
• Collaborating with Cardiologists and Electrophysiologists (EPs) and Key Opinion Leaders (KOLs) to identify unmet needs and define necessary solutions
• Build and sustain KOL relationships through clinical expertise and collaborate with other functions interfacing with customers / physicians
• Articulates value proposition of our innovation externally and defends innovation when necessary within competitive environment
• Continuously seek ways to improve customer experience and implement initiatives to enhance satisfaction and loyalty
• Builds strong internal relationships/partnerships and enhances collaboration by breaking down silos across the organization
• Provides counsel on large / complex product research projects in preparation for health authority submissions
• Defining and overseeing the evidence required for market approval of new solutions in Ultrasound imaging and LAAE and structural heart
• Serve as voice of customer across broad range of business topics to ensure strong customer-centric mindset and clinical applicability
• Provides clinical perspective to Commercial, Marketing, Evidence Generation, Education, R&D, Regulatory, Clinical and Health Economics and Market Access in support of the development of strategy and product development opportunities
• Leading technology assessment in partnership with new business development
• Supports medical education team to ensure the relevant teams are on the forefront of emerging science, surgery, trends, technologies, and unmet needs
• Innovates and advances training programs that address educational gaps among clinical professionals aligned with company strategy
• Responsible for leading the creation of Life Cycle Medical affairs (e.g., copy review, medical information requests, medical input CERs, etc.)
• Helps to inform business and cross functional partners what will be accepted in industry to alleviate economic challenges within hospital environment

Requirements

• Medical degree (MD or equivalent) with a strong background in cardiology or related field
• Experience in medical affairs, clinical development, or related roles in the medical device or pharmaceutical industry
• Proven leadership experience in managing cross-functional teams and projects
• Strong understanding of regulatory requirements and compliance in the medical device industry
• Excellent communication and interpersonal skills to engage with KOLs, regulatory bodies, and internal stakeholders
• Ability to analyze complex clinical data and provide strategic insights
• Experience in developing and executing medical strategies and plans

Nice-to-haves

• Experience in ultrasound imaging and Left Atrial Appendage Elimination (LAAE) technologies
• Familiarity with FDA regulatory processes and submissions
• Strong network within the cardiology and electrophysiology communities
• Experience in training and developing clinical teams
• Advanced degree (PhD or equivalent) in a relevant scientific field

Benefits

• Comprehensive health insurance
• 401(k) plan with company matching
• Paid time off and holidays
• Tuition reimbursement
• Employee wellness programs
• Flexible work arrangements
• Diversity and inclusion initiatives