Director, Medical Excellence, Electrophysiology

Johnson & Johnson Innovative Medicine•Irvine, CA

19h•$164,000 - $305,900•Hybrid

About The Position

Johnson & Johnson MedTech is developing the next generation of smarter, less invasive, and more personalized treatments in cardiovascular care, focusing on heart recovery, electrophysiology, and stroke. The Director, Medical Excellence, Electrophysiology will provide scientific, clinical, and Medical Affairs leadership for electrophysiology products and related software used in diagnosing and treating cardiac arrhythmias. This role is crucial for ensuring that medical strategies, evidence generation, scientific communications, claims, training, and product lifecycle activities are clinically meaningful, patient-centered, and compliant. The leader will translate clinical evidence and product insights into clear scientific communication and physician education, supporting evidence generation, data interpretation, claims substantiation, risk-benefit assessment, product launch readiness, and lifecycle management for the Electrophysiology portfolio.

Requirements

Advanced degree in life sciences, medicine, engineering, biomedical engineering, or a related scientific discipline is required.
A minimum of 10+ years of relevant healthcare industry experience in one of the following functions: e.g. Medical Affairs, Clinical Research, Scientific Affairs, R&D, Regulatory Affairs, Quality, or a related function within the medical device sector is required
Therapeutic experience in cardiovascular is required.
A minimum of 3 years of relevant experience directly in Medical Affairs is required.
Demonstrated experience interpreting complex clinical, scientific, technical, or product performance data to support scientific strategy, evidence generation, claims, publications, regulatory submissions, or product lifecycle decisions is required.
Working knowledge of applicable regulatory and compliance expectations, including FDA, MDR, Good Documentation Practices, promotional review principles, fair balance, and appropriate use of scientific and clinical evidence is required.
Strong knowledge of medical device development, clinical evidence requirements, scientific review, claims substantiation, and compliant communication standards in a regulated healthcare environment is required.
Experience reviewing or contributing to scientific, educational, promotional, training, publication, regulatory, or clinical study materials is required.
Demonstrated ability to collaborate across R&D, Clinical Research, Regulatory Affairs, Quality, Compliance, Marketing, Commercial, Health Economics, and Professional Education functions is essential.
Strong written and verbal communication skills, with the ability to translate complex scientific and technical information into clear, accurate, and audience-appropriate communications are necessary.
Proven ability to work effectively in a multidisciplinary, global matrix environment and influence cross-functional stakeholders is required.

Nice To Haves

Previous experience working with device and technologies in the electrophysiology space is highly preferred.
Strong strategic thinking, leadership, stakeholder management, negotiation, and organizational skills are an asset.
Demonstrated success in evidence generation, clinical data interpretation, publication strategy, scientific communications, or medical education is preferred.

Responsibilities

Provide Medical Affairs leadership and scientific expertise for electrophysiology products, software-enabled technologies, and related clinical workflows across the product lifecycle.
Partner with R&D, Clinical Research, Regulatory Affairs, Quality, Compliance, Health Economics, Professional Education, Marketing, and Commercial teams to shape integrated medical evidence to support product development, regulatory submissions, claims, launch readiness, training, and post-market evidence needs.
Lead the medical review and interpretation of clinical, preclinical, real-world, and product performance data to support evidence generation, claims development, physician education, publications, regulatory documentation, and lifecycle management.
Contribute to evidence generation strategies for company-sponsored studies, investigator-initiated research, registries, post-market studies, and other scientific initiatives aligned to business, clinical, regulatory, and patient-care priorities.
Provide scientific input and oversight for clinical trial concepts, study design, evidence capture, data analysis, reporting, and dissemination in assigned areas of responsibility.
Collaborate with Clinical Research, Biostatistics, Regulatory Affairs, and other cross-functional partners to prepare clinical investigation reports, scientific summaries, regulatory responses, publication materials, and evidence packages.
Review and approve scientific, educational, promotional, reporting, and training materials to ensure accuracy, fair balance, appropriate substantiation, and alignment with applicable regulatory, legal, compliance, and Medical Affairs standards.
Support scientific communications and publication planning by prioritizing publication concepts, reviewing abstracts and manuscripts, and ensuring data are communicated accurately and responsibly.
Engage with healthcare professionals, key opinion leaders, professional societies, payers, and providers to understand evolving standards of care, unmet clinical needs, evidence gaps, and opportunities to advance patient-centered innovation.
Partner with Medical Safety, Quality, Clinical Research, and Regulatory Affairs to review, trend, and escalate safety or performance-related information from clinical studies, post-market activities, and product use as appropriate.
Provide medical and scientific input into risk management activities for new and lifecycle products, including benefit-risk assessment, clinical workflow considerations, software-related risks, and final risk management documentation.
Support commercial launch and field readiness by helping translate evidence into clear scientific messaging, physician training, clinical workflow guidance, and responsible product education.
Review product performance and clinical-use data from CARTO and other relevant sources to identify insights that may inform training, workflow optimization, evidence needs, and future product improvements.
Operate effectively in a global matrix environment, influencing without authority and building strong partnerships across functions, regions, and external stakeholders.