Director, Medical Affairs, Electrophysiology - Irvine California

Company: Disability Solutions
Location: Irvine, California
Posted On: 02/04/2025

Johnson and Johnson is currently seeking a Director, Medical Affairs, Electrophysiology located in Irvine, CA.\rAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.At Johnson & Johnson, we all belong.Atrial fibrillation (AFIB) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. Over 20 million people around the world suffer from AFIB each year. Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company's CARTO-- 3 System in 2009 revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure. The company has a high cadence of innovation and offers a broad portfolio of devices to treat arrhythmias. Our environment is innovative, entrepreneurial, learning-driven, and is as challenging as it is rewarding.\rThe Director will have medical affairs responsibility in providing therapeutic and clinical expertise in support of the development of medical devices for the treatment of arrhythmias and structural heart disease. This role will also have preclinical operations responsibility for the entire PFA Platform, including quality review and compliance to GLP guidelines. This role will provide strong strategic input on long term product opportunities and portfolio strategies, work closely with the Clinical Research team in support of evidence generation and dissemination activities that support product approvals, claims development, and product adoption and lifecycle management, and work closely with the R&D teams during product development and with marketing and commercial teams during product launches to provide training and education. The Director will help shape the industry and build strong relationships externally with key customers and stakeholders (Key Opinion Leaders, Surgeons, Regulatory Agencies, Professional Societies, etc.) to anticipate industry trends, understand clinical/medical insights, unmet medical needs and global standards of care to deliver quality products/solutions.\r\r\rThe Director - Medical Affairs will:

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• Work with business partners including but not limited to R&D, Clinical Research, Regulatory Affairs, Quality & Compliance, Health Economics & Market Access, and Professional Medical Education to influence overall regulatory and commercial strategy, as well as support product development, pre- and post-approval clinical studies, downstream claims, safety assessments, and product launch and training.
• Lead the support for all clinical studies - both for regulatory purposes as well as physician initiated collaborative studies. They will be responsible and accountable for case support plan and execution, physician training, internal field training, training materials, data analysis, publication support and collection of data for supporting platform claims.
• Support the commercial launch of the platform by activating sites, providing physician training, and collect regular feedback on product performance and improvements.
• Contribute to the development and execution of product and/or procedural evidence generation and dissemination strategies for company sponsored and investigator initiated research.
• Participate in governance forums including Business Unit leadership teams, cross-functional product core teams, EGS teams, portfolio/strategy management teams, and Safety and Quality Review Boards.
• Engage Key Opinion leaders, Professional Societies, Payers and Providers to understand trends in care and uncover critical insights to support product innovation
• Provide support to Marketing, R&D, Communications, Legal, Quality Assurance/Risk Management/Product Safety and Commercial teams by providing medical and scientific insights to drive optimal business strategic direction and tactical business activities
• Collaborate with evidence generation colleagues from Preclinical Research and Clinical Research teams in the USA and internationally to develop global strategies for evidence generation for new and existing products in order to support regulatory approval/clearance, health technology assessment, customer access and post-marketing support
• Provide scientific expertise, oversight and approval for clinical trial concept, design, analysis and reporting of clinical research in assigned areas
• Provide oversight for the development of materials to be used for study execution (investigator brochures, training materials, etc.)
• Work closely with Medical Safety team to ensure adverse events from clinical research studies are reviewed, trended and escalated as needed
• Provide scientific input and expertise in the analysis of study results
• Work with Regulatory and Clinical partners to prepare report on clinical investigations in preparation for submission to regulatory agencies and/or for publication, to meet evidence requirements
• Provide medical insights/expertise to the development teams for the risk assessment review for new products and reviews and approves the final risk management report for all new products
• Account for the medical content of internal product documentation and regulatory submissions for new products and for renewals.
• Approve Design History Files, Technical Guides and Clinical Evaluation Reports (CERs) as part of the creation of product-specific design dossiers/technical files
• Reviews and approves educational, promotional and reporting materials for use by internal stakeholders. Strategizes and prioritizes publication proposals in collaboration with Clinical Science.
• Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures\r\r\r More...

      

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