CMSO, APAC and Preclinical Advisor
Johnson & Johnson · Irvine, California, United States of America
Job description
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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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
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