Director, Medical Affairs, Electrophysiology

Johnson & Johnson•Irvine, CA

11h•Onsite

About The Position

Johnson and Johnson is currently seeking a Director, Medical Affairs, Electrophysiology located in Irvine, CA. This role 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. The Director will provide strong strategic input on long term product opportunities and portfolio strategies, work closely with the Scientific Affairs 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.

Requirements

Bachelors degree in Medicine, Biomedical/Mechanical Engineering, or equivalent life sciences/technical engineering discipline is required.
Minimum 10 years of relevant business experience in product development, within the Cardiovascular industry is required.
A minimum of 3 years of relevant experience directly in Medical Affairs is required.
Proven track record of the ability to learn complex technology/clinical applications is required.
Demonstrated success in medical data generation, interpretation and publications is required.
Excellent strategic thinking, communication, and stakeholder‑management skills are essential.
Strong knowledge of regulatory, compliance, and ethical requirements governing Medical Affairs activities is required.
Strong leadership skills and demonstrated ability to build successful relationships with internal and external partners globally is required.
Strong communication and negotiation skills to successfully influence and implement policy with key customers and partners is critical for success in this role.
A proven ability to collaborate well with multiple partners and work effectively in a highly matrixed environment is required.

Nice To Haves

Advanced degree MD, PharmD or PhD in Medicine, Biomedical Engineering, or equivalent life sciences discipline is highly preferred.
Previous Medical Affairs and/or Medical Science Liaison experience in a regulated, commercial medical device business is strongly preferred.
Previous clinical experience in the electrophysiology space is highly preferred.
Minimum 10 years of experience supporting clinical cases and proctoring cases is preferred.

Responsibilities

Work with business partners including but not limited to R&D, Clinical & Pre-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.
Lead the support for all clinical studies – both for regulatory purposes as well as physician initiated collaborative studies.
Be responsible and accountable for case support plans 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 to collect and provide 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 and HEMA needs.
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.