Job Function:
Medical Affairs Group

Job Sub Function:
Medical Affairs - MD

Job Category:
Scientific/Technology

All Job Posting Locations:
Irvine, California, United States of America

Job Description:

Chief Medical & Scientific Officer, APAC and Preclinical Advisor

Location: Irvine, CA

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.

Purpose:

We are seeking a dynamic and experienced Chief Medical & Scientific Officer, APAC and Preclinical Advisor to be located in Irvine, CA. This role will report to the Chief Medical & Scientific Officer, Electrophysiology.

The CMSO, APAC and Preclinical Advisor will:

Preclinical Advisor: Provide clinical and scientific leadership to inform global guidelines, trial and evidence strategies to shape and influence the global medical and scientific strategy for electrophysiology across discovery to clinical development. It translates preclinical and translational data into regulatory-ready development and clinical plans, accelerates innovation by partnering with R&D, translational and commercial teams, and establishes global standards for clinical development, data generation, regulatory strategy, and ethics. It guides product portfolio and lifecycle governance, shapes guidelines and trial strategies globally, and works with regional medical offices with evidence generation and pivotal/post-market study design and helps to shape MSL programs through training and scientific oversight.

Asia Pacific: Lead the Medical Office for Strategic Markets across Japan, North Asia and ANZ by defining and executing vision, goals and APAC best practices aligned with company strategy. Set regional medical direction for electrophysiology, converting global strategy into local clinical and development plans while ensuring regulatory and ethical compliance. Accelerate regional innovation through partnerships with Global R&D, local preclinical, Global CMSO and commercial teams to identify and convey region-specific clinical evidence needs. Represent J&J externally with KOLs, societies and regulators; serve on the EP APAC Leadership Team; guide MSLs, shape product strategy, support commercialization, and report to the Global CMSO.

You will be responsible for:

CMSO - Preclinical Advisor

• Leadership: Define the global medical direction and scientific strategy for electrophysiology across discovery, preclinical, translational, and clinical development, aligning priorities with company strategy. Serve as member of Global CMSO Leadership Team
• Evidence Based and Modeling: Partner with preclinical, engineering, and translational teams to design, evaluate, and interpret experiments, advising on clinically relevant models, study methodologies, and evidence-generation approaches.
• Portfolio, Systems & Workflow Integration: Provide strategic input on experimental design, product evaluation and safety assessment for electrophysiology technologies, energy platforms, mapping systems, and procedural workflows.
• Medical Translation: Provides counsel on large / complex product research projects in preparation for health authority submissions. Translate preclinical and translational findings into coherent development and clinical plans that support regulatory approval, clinical adoption, and risk mitigation.
• Portfolio Architect: Set global standards and best-practice frameworks for clinical development, data generation, regulatory strategy, ethical compliance, and govern product portfolio, labeling and lifecycle management. Provides clinical perspective to Commercial, Marketing, Evidence Generation, Education, R&D, Regulatory, Clinical, Preclinical and Health Economics and Market Access in support of the development of strategy and product development opportunities
• Medical Expert: Provide authoritative clinical and scientific leadership in guideline, trial, and regulatory fora; oversee regional medical offices and MSL programs to ensure consistent scientific quality, training, and commercialization-aligned evidence generation.

CMSO - Asia Pacific

• Leadership: Lead the Medical Office for Strategic Markets across Japan, North Asia and ANZ: develop and execute vision, mission and goals, and assure seamless knowledge transfer from global medical to the Strategic Markets within APAC and serve on the Asia Pacific EP Leadership team to work cross-functionally shaping product portfolio strategy, supporting commercialization of new and legacy products, and identifying region-specific clinical evidence needs
• Medical Expert: Define medical direction for electrophysiology in Strategic Markets across Japan, North Asia, and ANZ by translating global strategy into locally actionable clinical and development plans; provide deep procedural insights to identify unmet needs, inform the franchise innovation agenda, and contribute to Target Product Profiles. Ensuring 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.
• Innovation Architect: Drive innovation and evidence generation by partnering with R&D, preclinical, engineering, translational medicine and commercial stakeholders to design, evaluate and interpret studies, select clinically relevant models, and convert findings into regulatory ready development and clinical plans. Evaluate external business development opportunities for JNJ MedTech, Electrophysiology, including participation in diligence activities.
• External Representation: Serve as J&J's external medical representative in Strategic Markets across Japan, North Asia, and ANZ: build and sustain KOL, academic and regulator relationships, lead advisory boards, articulate and defend our value proposition, and shape product portfolio, lifecycle, and commercialization strategies through identification of unmet needs. Reviews and approve key regulatory submissions and communications with the regulatory bodies in Japan, North Asia, and ANZ cluster. Articulates value proposition and defend, when necessary, of our innovation externally, while ensuring customer-centricity
• Medical Safety: Provide medical safety, risk, and regulatory oversight-independently evaluate clinical risk, lead adverse event reporting and Field Action processes, analyze signals and trends from clinical data, literature, and complaints, and inform evidence-based risk/benefit decisions and regulatory submissions.
• Cross-Functional Collaborator: Lead cross functional medical collaborations and capability building: provide strategic direction to medical affairs, partner closely with MSLs on NPD and LCM projects, oversee medical education and governance, ensure field activities and clinical perspectives drive customer centric strategy and global alignment.

Requirements:

• MD with practical knowledge and insights into Electrophysiology
• Class III Medical Device experience is required.
• Experience in clinical / hospital environment
• Extensive experience (>10 years) in Electrophysiology or the diagnosis and treatment of AFib or Persistent AFib
• Required Years of People Management Experience: 10+ years.
• Demonstrated expertise and excellence in Electrophysiology 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
• 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.
• Ability to collaborate across different functional areas to ensure alignment with governance processes to meet business objectives.
• Leadership requirement - ability to influence, shape and lead without direct reporting authority.
• Possesses high emotional intelligence; possess excellent oral and written communication skills; possess excellent interpersonal skills for interactions with internal colleagues and external customers.
• Up to 50% domestic and international travel

• Extensive experience designing, conducting, and interpreting translational and preclinical electrophysiology studies supporting medical device innovation and evidence generation.
• Demonstrated expertise in the evaluation and development of electrophysiology technologies, including mapping systems, ablation platforms, lesion assessment methodologies, and procedural workflow optimization.
• Deep understanding of clinically relevant preclinical models, experimental methodologies, and tissue characterization techniques used to evaluate cardiac electrophysiology devices, safety profiles, and therapeutic performance.
• Proven ability to collaborate effectively with R&D, engineering, preclinical, and industry partners to guide technology development from early concept through clinical translation.
• Extensive experience providing scientific and clinical input into experimental design, study endpoints, data interpretation, and technology validation strategies supporting regulatory, clinical, and commercial objectives.
• Recognized expertise in translational electrophysiology research with a strong track record of peer-reviewed publications, innovation partnerships, and physician education
• Track record of successful new product introductions to the market.

• 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 local regulatory bodies in the Japan, North Asia and ANZ Cluster and the rest of APAC.
• Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders.
• Experience in effective management of project budget processes
• Ability to lead and influence others in a complex matrix organization.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :
$232,000.00 - $401,350.00

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.

Subject to the terms of their respective plans, employees are 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.

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