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 – MD **Job Category:** People Leader **All Job Posting Locations:** US180 CA Irvine - 29A Technology Dr **Job Description:** Johnson and Johnson is currently seeking a **Head of Medical Affairs, Structural Heart** located **in Santa Clara, CA or remote for the ideal candidate in the United States.** 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/_ . At Johnson & Johnson, we all belong. The Head of Medical Affairs, Structural Heart will oversee the Pre-Clinical, Field Clinical and Post-Market Commercial Products teams under Medical Affairs. This position is responsible for developing and executing the vision, mission and goals for the Medical Office, in alignment with the company’s business strategy. This position will play a pivotal role in shaping the medical direction of our Ultrasound imaging and Left Atrial Appendage Elimination (LAAE) Platform Technologies, ensuring compliance with regulatory standards and driving innovation in medical technology development. This role will provide medical and scientific leadership expertise in the area of Ultrasound imaging and LAAE and the management of patients in related clinical disciplines. The successful candidate will report directly to the VP of Scientific Affairs and will work closely with cross-functional teams to develop strategy and achieve business objectives. **Major Duties and Responsibilities:** **Organizational Leadership: Oversight of Pre-Clinical, Field Clinical; and Post-Market Evaluation for Structural Heart** + Provide deep surgical insights, gather, assimilate, and translate opportunities to address unmet surgical needs to inform the Franchise innovation agenda + Responsible for building our Global Field Clinical team with training assets and proctor program + Provides medical input into Target Product Profile + Risk management and safety oversight across end-to-end processes, including medical input into adverse event reporting, complaints, Health Hazard Evaluations, Field Action Committee and Complaint Review Board. + Ability to provide independent, medical input to critically evaluate clinical risk, and make evidence-based risk benefit determinations / assessments. + Lead medical input into critical business decisions regarding potential patient safety issues. + Analysis and interpretation of signals and trends from multiple inputs including clinical data, literature, complaints, etc. Provides strategic direction to members of the medical affairs department. + Oversee the Pre-Clinical, Field Clinical and Post-Market launch organizations for Medical Affairs - Responsible for managing operational aspects of their teams (e.g., budget, performance, and compliance), as well as implementing workforce and succession plans to meet business needs. **External Engagements: KOLs / Ad Boards / Physicians / Academic Institutions / FDA** + Bring and develop strong relationships with the top academic clinical physician leaders in the field of Left Atrial Appendage and related clinical fields + Develop and sustain strong relationships with senior leaders at the FDA + Reviews and approve key regulatory submissions and communications with the FDA and other regulators + Collaborating with Cardiologists and Electrophysiologists (EPs) and Key Opinion Leaders (KOLs) in to identify unmet needs and define the necessary solutions to inform strategies for customer collaboration, innovation, education, and strategic partnerships, not limited to, but particularly focused on LAAE and Electrophysiology + Develop relationships with top academic leaders who are investigating Ultrasound, LAAE and Electrophysiology or leading clinical trials in the space + Build and sustain KOL relationships through clinical expertise and collaborate with other functions interfacing with customers / physicians + Articulates value proposition of our innovation externally and defends innovation when necessary within competitive environment + Provides appropriate messaging to external KOLs and strategic ad-boards regarding the future of Ultrasound imaging and mapping and LAAE and direction we can take to continue leadership in these spaces + Continuously seek ways to improve customer experience and implement initiatives to enhance satisfaction and loyalty **Cross Function Leadership & Collaborations** + Builds strong internal relationships/partnerships and enhances collaboration by breaking down silos across the organization + Provides counsel on large / complex product research projects in preparation for health authority submissions + Defining and overseeing the evidence required for market approval of new solutions in Ultrasound imaging and LAAE and structural heart. Work closely with org reports in Pre-Clinical, Field Clinical and Medical Science Liaisons to develop and implement clinical evidence strategy + Serve as voice of customer across broad range of business topics to ensure strong customer-centric mindset and clinical applicability. Represent customer perspective in strategic discussions, ensuring customers’ needs and perspectives are prioritized in decision making process + Provides clinical perspective to Commercial, Marketing, Evidence Generation, Education, R&D, Regulatory, Clinical and Health Economics and Market Access in support of the development of strategy and product development opportunities + Lead medical input into critical business decisions regarding potential patient safety issues + Leading technology assessment in partnership with new business development. Informing target selections and technology opportunities aligned with strategic portfolio priorities + Supports medical education team to ensure the relevant teams are on the forefront of emerging science, surgery, trends, technologies, and unmet needs through presence at key scientific meetings, relationship management with leading research physicians, medical delivery systems and government decision makers, critical evaluation of current literature and competitive activity, and in other domains where surgical / medical expertise is required + Innovates and advances training programs that address educational gaps among clinical professionals aligned with company strategy + Responsible for leading the creation of Life Cycle Medical affairs (e.g., copy review, medical information requests, medical input CERs, etc.) + Helps to inform business and cross functional partners what will be accepted in industry to alleviate economic challenges within hospital environment **Qualifications - External** + Board Certified MD with practical Cardiology experience + Class III Medical Device experience is required + Experience in an academic clinical / hospital environment + Extensive clinical practice experience (>10 years) in Structural Heart, LAA and/or Cardiology and/or Electrophysiology + Demonstrated expertise and excellence in LAA or Structural Heart of clinical practice and be recognized as a U.S. or international leader in publications, education and research in this area + In-depth knowledge of clinical trial design, regulatory requirements, and healthcare compliance + Strong understanding of medical device development processes and lifecycle management + Excellent communication skills with the ability to articulate complex medical and scientific concepts effectively + High ethical standards and commitment to patient safety and healthcare quality + Experience in customer relationship management with VOC focus + Understands clinical trends and the Cardiovascular market environment, with connections in the digital / med tech ecosystem + Proven ability to be strong advocate for patient-centric and customer-centric decision making + Highly reputable externally and is capable of building key relationships and influencing externally and internally + Has strong relationships / experience to successfully work with FDA + Ability to lead and influence others in a complex matrix organization + Broad technical and business expertise and understand clinical disease state needs + Knowledge of medical device regulations and external standards is preferred + Track record of successful new product introductions to the market + Ability to lead a team of Pre-Clinical, Field Clinical and MSLs to provide strategic and scientific clinical research input across NPD and LCM projects + Ability to lead teams to deliver critical milestones + Ability to collaborate across different functional areas to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives + Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders + Leadership requirement – ability to influence, shape and lead without direct reporting authority + Change agent in team progression + Experience in effective management of project budget processes + Through transparent leadership, be a key leader in developing a high-performing team with a global culture + Possesses high emotional intelligence; possess excellent oral and written communication skills; possess excellent interpersonal skills for interactions with internal colleagues and external customers + Ability to lead and influence others in a complex matrix organization + Ability to Travel 50% Domestic and Internationally + Must have 10 years of People Management Experience (2-3 direct reports) The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com . Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement. For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits **The anticipated base pay range for this position is :** The anticipated base pay range for this position is 226000 to 391000. California Bay Area - The anticipated base pay range for this position is 260000 to 449650. Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. · Please use the following language: Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market."