J&J Family of Companies Sr. Medical Director, APAC Preclinical, Clinical and Medical Affairs, Ethicon in Shanghai, China
Senior Medical Director APAC Preclinical, Clinical, Medical Affairs, ETHICON
ROLE AND KEY RESPONSIBILITIES:
This position will report into the Global Ethicon Franchise PCM Leader and will serve as the APAC regional PCM SME, sit on the Global Franchise PCM LT, and serve as a strategic partner with colleagues in other functions, including but not limited to R&D, Global Strategic Marketing, Commercial, and HEMA (Health Economics and Market Access). This person will provide the APAC input to the global Ethicon franchise PCM portfolio and evidence generation strategies, and will work closely with the country/cluster PCM leaders (e.g., China, Japan, N. Asia, ANZ, India) who will lead the local execution of the global strategy. This individual will provide expert medical and scientific input while capturing region specific insights to product ideation and development, including conceptual and hands-on product evaluation as well as medical and clinical research and regulatory perspectives. This role will collaborate closely with the cross-functional partners throughout the product lifecycle as a strategic partner.
Additionally, this role will also
• Provide strategic input to the Ethicon franchise innovation portfolio and EGS/EDS efforts based on needs assessed in APAC in collaboration with local cross-functional partners as well as with external physicians. Will serve as a primary liaison between the global Ethicon franchise PCM team and the APAC country/cluster PCM teams to ensure global alignment. Will provide the global Ethicon franchise perspective and strategies to the APAC leadership team.
• Serve as a strategic partner with colleagues in multiple functions to develop regional/country-specific strategies for evidence generation and dissemination for new and existing products to support regulatory approval/clearance, health technology assessment, market access and post-marketing support for key products within the Ethicon franchise portfolio. Will maintain strong alignment with the global PCM leader to ensure portfolio and EGS alignment to enable a strong global strategy with strong local execution.
• Provide medical interpretation of study outcomes and assists with the development of communication and education strategies for the dissemination of the results.
• Will engage in environmental scanning and competitive analysis, new product development, clinical research, new business development, product training during investigational trials as well as during product launches, and may provide case coverage during trials. Works closely with cross-functional and cross-regional colleagues and provide expert medical and scientific input, including conceptual and hands-on product evaluation, and medical or clinical research perspectives.
• Provide scientific and medical expertise and oversight for concept, design, analysis and reporting of clinical research in assigned areas, to meet regional therapeutic evidence requirements. May approve clinical investigation reports and publications from region/country-specific studies in preparation for submission to regulatory agencies and/or for publication.
• May oversee physicians (internal or consultants) who perform the role of medical monitor for company sponsored clinical studies. May perform the role of medical monitor for certain company sponsored clinical studies and will work closely with the regional Medical Safety group for issues related to product safety surveillance.
• Provide regional/country-specific input to strategies for communication of clinical and non-clinical data.
• May oversee the activities of Region/Country/Product-assigned Medical Science Liaisons.
• Serve as a key contact between relevant franchise units and national/regional registries.
• Support the APAC PCM group for Medical Information Requests.
• Provide medical advice input to regional product Complaint Handling, Investigation and Escalation.
• Experience and focused training in the Ethicon franchise clinical areas is required
• MD/MB/DO and a minimum of 10 years relevant experience in post graduate medical education (beyond initial licensure) including: specialty residency, fellowship or subspecialty training, clinical practice, dedicated research, or other related advanced training/experience is required; or PhD with 10+ years of industry experience in the relevant therapeutic space.
• A current license to practice is preferred and Board Certification in surgical specialty or an equivalent is strongly preferred
• Significant experience with clinical research is required
• Strong leadership skills and demonstrated ability to build successful relationships with internal and external partners globally
• Strong communication and negotiation skills to successfully influence and implement policy with external physicians and partners.
• Previous industry experience leading Medical/Clinical/R&D teams in a regulated, commercial biomedical or medical device business is preferred
• Membership and leadership roles in surgical specialty Professional Societies is desirable
• Capability, expertise and success in building teams to meet the needs of a global set of businesses serving different clinical specialties or therapeutic areas will be needed.
• Demonstrated success in medical data generation, interpretation and publication highly preferred
• Experience in product risk evaluation and mitigation is preferred
• Fluency in English both written and spoken is required, other APAC region languages are a plus.
• Strong leadership required in alignment with J&J Leadership Imperatives by building a trusting, collaborative, and ethical work environment, maintaining the highest standards of quality, compliance and acceptability.
• Connect - foster strategic partnerships with key internal & external stakeholders to ensure development and timely delivery of innovative EGS / EDS. Be insight-driven to uncover unmeet needs.
• Shape – build strong relationships with external stakeholders to shape and influence relevant policies
• Lead – build and develop talent to provide strategic and scientific evidence generation capability
• Deliver – ensure regional evidence generations needs are understood, executed and in compliance to regulations and SOPs
Asia Pacific-China-Shanghai-Shanghai, Asia Pacific-Japan-Shinagawa-Tokyo
Johnson & Johnson Pte. Ltd. (8435)
J&J Family of Companies
- J&J Family of Companies Jobs