Director, Medical Affairs, Electrophysiology

At 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

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Affairs – MD

Job Category:

People Leader

All Job Posting Locations:

US180 CA Irvine - 29A Technology Dr

Job Description:

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Johnson and Johnson is currently seeking a Director, Medical Affairs, Electrophysiology located in Irvine, CA. 

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.  

The 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.
 

The Director – Medical Affairs will:

• 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