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Medical Director, Structural Heart

10 years
Not Disclosed
10 Dec. 8, 2025
Job Description
Job Type: Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Medical Director, Structural Heart

Location: Irvine, California, United States
Work Model: Hybrid
Category: Director, Medical Affairs
Function: Medical Affairs Group
Requisition ID: R-032552
Application Deadline: December 12, 2025


About the Role

Johnson & Johnson is seeking an experienced Medical Director, Structural Heart to provide strategic medical leadership within our MedTech division. This role is central to advancing the development, evaluation, and commercialization of innovative medical devices for structural heart disease. The Director will guide clinical strategy, regulatory alignment, product innovation, and global scientific collaboration.

This hybrid role is based in Irvine, California, with applications open to candidates across regions.


About Johnson & Johnson MedTech

Johnson & Johnson MedTech combines biological insight and engineering excellence to deliver next-generation, minimally invasive, and personalized treatment solutions. The Structural Heart team is dedicated to elevating care standards for patients with complex cardiovascular conditions, collaborating across heart failure, electrophysiology, and stroke solutions.


Role Purpose

The Medical Director will oversee medical affairs strategy for structural heart interventions. Responsibilities include clinical leadership, evidence generation, regulatory support, product lifecycle planning, and cross-functional collaboration with R&D, Clinical Research, Marketing, Regulatory Affairs, and Commercial teams. The role also requires strong external engagement with Key Opinion Leaders, Interventional Cardiologists, regulatory bodies, and global professional societies.


Key Responsibilities

Clinical Leadership

  • Lead clinical studies, including regulatory trials and physician-initiated research.

  • Oversee case support, physician training, field training, clinical materials, and data analysis.

  • Support evidence generation strategies for product approvals, claims development, and post-market activities.

  • Provide scientific oversight for clinical trial design, concept development, analysis, and reporting.

  • Develop study-related materials such as investigator brochures and training documents.

  • Collaborate with Medical Safety teams to monitor and assess adverse events.

  • Prepare and review clinical documentation for regulatory submissions and publications.

  • Ensure compliance with patient safety standards.

  • Approve design dossiers, technical guides, and Clinical Evaluation Reports.

  • Review and authorize internal educational and promotional materials.

  • Prioritize scientific publications in collaboration with Clinical Science teams.

Cross-Functional Leadership

  • Partner with R&D, Regulatory Affairs, Quality, Business Development, Market Access, and Professional Education teams.

  • Contribute to regulatory and commercial strategy for structural heart innovations.

  • Serve on governance forums and cross-functional leadership committees.

  • Support global product launches, including site activation, physician onboarding, and performance monitoring.

  • Provide scientific insights to Marketing, Communications, Legal, Product Safety, and Commercial teams.

External Engagement

  • Engage Key Opinion Leaders, academic centers, payers, and professional societies to identify emerging trends and unmet needs.

  • Build relationships with global experts in structural heart interventions.

  • Collaborate with field teams interacting with structural heart physicians and customers.

  • Travel up to 35% domestically and internationally.

Program Oversight and Team Development

  • Align medical strategy, budgets, and resources to organizational goals.

  • Recruit, mentor, and support the Structural Heart Medical Affairs team.

  • Ensure compliance with corporate health, safety, environmental, and regulatory protocols.

  • Uphold federal, state, and company policies and standards.


Required Education

  • Medical degree (MD, DO, or equivalent).

  • Formal training in Interventional Cardiology is required.


Required Experience

  • Minimum 10 years of experience in structural heart interventions, cardiac device development, or related specialties.

  • Demonstrated experience in clinical research, trial oversight, and medical data analysis.

  • Strong knowledge of cardiovascular devices and structural heart technologies.

  • Hands-on experience in product development for structural heart interventions.

  • Proven leadership experience managing teams in complex, matrixed environments.

  • Experience working in regulated medical device or biomedical industries.

  • Track record of scientific publications and evidence generation.

  • Experience in product risk evaluation and mitigation.

  • Strong communication, stakeholder engagement, and negotiation skills.

  • Ability to travel up to 35% internationally and domestically.


Preferred Experience

  • Prior leadership of Medical or Clinical teams in global commercial biomedical organizations.

  • Experience supporting product launches and downstream claims development.

  • Expertise in global clinical strategies for regulatory approval and market expansion.


Compensation and Benefits

  • Anticipated salary range: USD 160,000 – 276,000.

  • Comprehensive benefits include 401(k), pension, health coverage, paid time off, wellness programs, and parental leave.


Equal Opportunity Commitment

Johnson & Johnson is an Equal Opportunity Employer. All qualified candidates will receive equal consideration regardless of legally protected characteristics. Applicants requiring accommodation may contact the careers support team.