招聘人数:1-2人
到岗时间:不限
年龄要求:不限
婚况要求:婚姻状况
? Provide strategic directions required for the successful planning and execution of clinical work within various R&D projects in Emerge Markets and worldwide regions,
? Plan budgets and resource requirements to conduct cost-effective clinical insight generation programs that yield necessary information to allow timely product development decisions
? Demonstrate guiding the R&D team in carrying out assigned clinical and development programs by working with internal and external professionals to achieve Company objectives and business improvement goals
? From neuro/peripheral vascular treatment clinical science perspective, applies strong influencing skills during product development, registration and commercialization phases to ensure shorter product development process and faster time to market.
? Manage and direct clinical operation activities (including tissue test/animal study/ clinical study management, study monitoring, data management and medical writing, quality) and associated staff to ensure clinical programs are conducted in accordance with GCP, applicable regulations and SOPs
? Collects and represents customer views, observes the clinical issues and investigates the clinical expertise to identify unmeet customer needs in the high clinical values areas, provides medical/clinical input to tailored product R&D organization representing VOC to enable achievement of business objectives for new product development
? Manage and be responsible for clinical requirements in product specifications developed during the product development process.
? Actively develops and maintains strong relationships with Key Opinion Leaders to facilitate understanding of product utility in clinical settings and drives project(s) forward and prototype verification with those KOLs.
? Organizes and manages Medical Advisory Board meetings to evaluate new tailored product concepts, consolidates inputs from KOLs, determines key clinical requirements based on collected feedback, and ensure new concepts developed by the tailored product team endorsed by KOLs.
? Identify possible clinical collaboration sites in China and/or other countries, to conduct and observe tissue/animal testing and operation of equipment at customer/clinical sites, and responsible for the accuracy, completeness and regulatory compliance of all clinical study results for their assigned programs.
? Develops clinical validation strategies, clinical study plans, and clinical protocols to evaluate safety and clinical efficacy aspects of tailored products concept/prototype prior to product release. Assures that prototype clinical research program design meets scientific objective. Develops data analysis strategy for prototype clinical studies.
? Applies advanced understanding of regulatory and international standards (FDA, SFDA) under which clinical studies of medical devices are conducted.
? Bachelor of Clinical medicine required, Medical Doctor (MD) preferred
Experience:
? 3-5 years working experience as Surgeon in hospital, preferably as a neurological or vascular surgeon or interventionist
? 5+ years working experience in a top medical device company as Clinical Specialist/Clinical Scientist/ Clinical Manager preferred
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