Medical Director, Structural Heart
Medical Director, Structural Heart
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Job Description
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
Medical Affairs GroupJob Sub Function:
Medical AffairsJob Category:
People LeaderAll Job Posting Locations:
Irvine California United States of AmericaJob Description:
About MedTech
Fueled by innovation at the intersection of biology and technology were 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 thats 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 is a hybrid role available in Irvine CA. We invite candidates from any location to apply.
We are searching for the best talent forMedical 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.
What you will be doing:
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
Qualifications
Education
- A degree in medicine (MD DO etc.) with training in Interventional Cardiology is required.
Experience and Skills:
- Minimum 10 years relevant experience in related studies such as Structural Heart Interventions is required.
- Relevant business experience in product development for Structural Heart Interventions. is highly desired.
- 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.
- Demonstrated capability expertise and success in building teams to meet the needs of a global set of businesses is preferred.
- 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.
- 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.
- A willingness and ability to travel approximately 35% domestic and international is required.
The anticipated base pay range for this position is 160000 - 276000.
At Johnson & Johnson were on a mission to change the trajectory of health for humanity. That starts by creating the worlds 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.
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 () or contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is :
160000 - 276000Additional Description for Pay Transparency:
The anticipated base pay range for this position is 160000 - 276000Required Experience:
Director
Employment Type
Full-Time
