Medical Monitoring Conducts medical data review of trial data, including eligibility review Holds responsibility for site interactions in partnership with the Japan Clinical Lead or Clinical Scientist for medical questions and education (including safety management guidelines) Holds responsibility for assessment of key safety-related serious adverse events of R&D clinical trials in partnership with Worldwide Patient Safety and oversees safety narratives Collaborate with Japan Clinical Lead or Clinical Scientist and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations) Fulfills GCP and compliance obligations for clinical conduct and maintains all required training The range of CTP's medical accountability/responsibility differs in global vs local studies. For global studies, Japan CTP is assumed to assist global CTP as needed from local perspectives, e.g. provide local medical related input, resolve local medical related issues. Japan CTP could be expected to take a primary CTP role for local initiated trials or program Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Clinical Trial Physician In collaboration with the Japan Program Development Team such as Clinical Lead, designs and develops project/clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets Provides oversight and medical accountability for a group of studies Leads the analysis of benefit/risk for clinical development protocols and projects in a matrix team environment working with Japan TA Partners with Japan the Japan Program Development Team such as Clinical Lead to support executional delivery of studies (e.g., enrollment review, as well as adjudication for protocol violations, significant, non-significant deviations etc.) Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Holds strong expertise in the disease area by attending scientific conferences and ongoing review of the literature Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others MD is required, Ph.D. is highly recommended Deep/extensive knowledge on all over clinical development that is equivalent to 5-10 year-experiences Broad knowledge on full process of pharmaceutical development and its regulatory guidance/guidelines Ability to propose and execute improvement and innovation in TA and cross-TA works Skills of budget planning and resource management Good communication skills in both Japanese and English Strong leadership qualities with the ability to create a culture of collaboration and teamwork that fosters open communication, constructive conflict, and organizational flexibility Excellent interpersonal skills, with the ability to build relationships, act as a change agent, and adapt to rapidly changing organizational and business issues Broad and in-depth understanding of domestic and international issues relative to the industry Experience to assure business compliance and control within the compliance obligations, Sarbanes Oxley and other audit requirements Expertise in the components needed to execute an effective clinical plan and protocols Ability to deliver the outcomes under the ambiguity or complexity Ability to partner with people at all levels of the organization Ability for proactive proposal building and proactive action takings without detailed instructions Ability to respond flexibly to the changing project/task priorities and work assignments. Ability to influence and negotiate without specific authority. Ability to take a risk and to manage it without jeopardizing quality and/or compliance Ability to build action plans based on the organization vision Acts to makes a balance between short-term performance and long-term vision. Fluent in spoken and written English & Japanese for business is preferred