Shibuya Campus. Study with us in the new campus Tokyo:Shibuya, if youwant to find a job /work in Japan Get estimate. Different accomodations. Long term courses. Short termcourses. Contact us. ?:Self:study Room, Counseling Room, Library, StudentLounge, Cafes, Japanese:style Room.Join the original For Foreigners By Foreigners English job board in Japan. Sales, Marketing, Service, Teaching, and Tech jobs for foreigners in Japan From basic Japanese. Overseas Application OK. Resume creation. Highlights:NewsletterAvailable, Events Available, Articles Available.Clinical Development Lead, JapanJob Overview:The position takes a responsibility for medical contents in all clinical development programs in assigned therapeutic areas (such as dementia, movement disorders, neuromuscular, etc.) in Japan. The individual functions as a scientific and clinical development lead in Biogen Japan's development pipeline. He/she interacts with multiple levels of management within Biogen, external stakeholders in the medical community, along with global regulatory authorities to provide strategic leadership for Japan clinical development planning/execution based on in:depth knowledge of therapeutic areas and extensive experiences in clinical development. He/she should be a motivated builder who has strategic and innovative mindset and implementation skills.Principal Accountabilities:Be a medical and/or scientific lead as an owner of medical contents in the context of clinical development projects in JapanLeads medical and scientific discussion as a Biogen clinical representative with the Japanese regulatory agency in the processes of clinical trial notification and registration filingDevelops Integrated Development Plan (IDP):accountable for Japan clinical development strategies- Work closely with Japan program management team to integratethescientificrationale,regulatory requirements, operationalfeasibility,productdevelopment plan, and commercial goals tobuild a solidstrategicframeworkfor the Japanesecomponents ofthe IDP- Lead clinical development strategy discussion- Ensure that a Japanese strategic plan is fully aligned with a globalstrategy and is fully understood by a project teamExpands therapeutic knowledge in relevant areas, attend major scientific conferences to establish and maintain scientific collaboration with Japanese key medical expertsDevelops and maintains collaboration with program counterparts within R and D and Japan Medical and business unit teamsContributes to scientific education of employees to help understand enjoyment of scienceMDStrong clinical credentials and/or drug development experiences in the therapeutic areas combined with strong grounding in scientific researchMinimum Experience Requirements:Clinical development experience within in biopharmaceutical industry (at least 3 years in product development), focusing on four neurology therapeutic areas (neurodegenerative diseases, neuromuscular diseases, neuroimmunology and immunology, and others including acute neurology and neuropsychiatry)Experience working with regulatory agencies (PMDA experience preferred)Ability to lead scientific discussion on mechanisms of new research approaches, clinical endpoints, protocol design, or data interpretationEstablished or has ability to establish peer level relationships with therapeutic area opinion leaders worldwideDemonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environmentDemonstrated strategic and critical thinkingExcellent communication skills (oral and written) and excellent organizational skillsAbility to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skillsDE and I for Job PostingBiogen is an inclusive company of choice that advances the power of difference to drive innovative, equitable solutions. We are
