Medical Director, Structural Heart (Irvine)

Medical Director, Structural Heart

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.

This is a [hybrid] role available in Irvine, CA. We invite candidates from any location to apply.

Role Purpose

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 structural heart diseases. This position will play a pivotal role in shaping the medical direction of our structural heart business, ensuring compliance with regulatory standards and driving innovation in medical technology development. This role will provide strong strategic input on long term product opportunities and portfolio strategies related to structural heart interventions, 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, Interventional Cardiologists, 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.

What You Will Be Doing :

• 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.
• Contribute to the development and execution of product and / or procedural evidence generation and dissemination strategies for company sponsored and investigator initiated research.
• 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
• Account for the medical content of internal product documentation and regulatory submissions for new products and for renewals.
• Safeguard patient safety.
• Approve Design History Files, Technical Guides and Clinical Evaluation Reports (CERs) as part of the creation of product-specific design dossiers / technical files
• Review and approve educational, promotional and reporting materials for use by internal stakeholders.
• Strategize and prioritize publication proposals in collaboration with Clinical Science.

Cross Function Collaborations

External Engagements

Program Oversight and Team Development

Qualifications

Education

Experience and Skills :

The anticipated base pay range for this position is 160,000 - 276,000.

At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through innovative programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love! At Johnson & Johnson, we offer a variety of outstanding health and financial benefits, including competitive compensation, 401k, pension, medical, dental, and vision insurance, exercise reimbursement, flexible time off, paid volunteer and parental leave, and more! For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resour