Medical Director, Structural Heart

Johnson & Johnson Innovative Medicine•Irvine, CA

11d•Hybrid

About The Position

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 Job Category: People Leader All Job Posting Locations: Irvine, California, United States of America Job Description: About MedTech 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 This is a [hybrid] role available in Irvine, CA. We invite candidates from any location to apply. We are searching for the best talent for Medical Director, Structural Heart. 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.

Requirements

A degree in medicine (MD, DO, etc.) with training in Interventional Cardiology is required.
Minimum 10 years relevant experience in related studies such as Structural Heart Interventions is required.
Cardiovascular industry and structural heart interventions knowledge strongly preferred with proven ability to learn complex technology/clinical applications is required.
Significant experience with clinical research is required.
Strong leadership skills and demonstrated ability to build successful relationships with internal and external partners globally is required.
Previous people management experience is required.
Strong communication and negotiation skills to successfully influence and implement policy with key customers and partners is essential.
Must be able to collaborate well with multiple partners and work effectively in a matrix environment.
A willingness and ability to travel approximately 35% domestic and international is required.

Nice To Haves

Relevant business experience in product development for Structural Heart Interventions. is highly desired.
Demonstrated capability, expertise and success in building teams to meet the needs of a global set of businesses is preferred.
Previous industry experience leading Medical/Clinical teams in a regulated, commercial biomedical or medical device business is strongly preferred.
Experience in product risk evaluation and mitigation is preferred.
Demonstrated success in medical data generation, interpretation and publications is highly preferred.

Responsibilities

Clinical Leadership 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 Work with business partners including but not limited to R&D, Clinical Research, Business Development, 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.
Have a leadership role 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.
Support the commercial launch of the platform by activating sites, providing physician training, and collect regular feedback on product performance and improvements.
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
External Engagements Engage Key Opinion leaders, Professional Societies, Payers and Providers to understand trends in care and uncover critical insights to support product innovation
Develop relationships with top academic leaders who are investigating structural heart interventions
Collaborate with other functions interacting with structural heart interventions customers / physicians
Ability and willingness to travel up to 35% of the time
Program Oversight and Team Development Align strategy, budget and resource allocation in close partnership with the cross-functional partners.
Recruit, mentor, and support the professional growth of the Structural Heart Interventions Medical Affairs team
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

Benefits

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year
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!

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume