Job Title Japan CDMA Lead Requisition JR000015023 Japan CDMA Lead (Open) Location CC-Japan - JPN511 Additional Locations Tokyo, Japan Job Description Summary This position requires the ability to read, write and speak Japanese at a native level. Japan CDMA Lead supports the scientific strategy for clinical trials in the development of drugs in Japan, and is responsible for conducting clinical trials based on the Clinical Development Plan and supporting operations through to approval. In addition, this position supports the evidence generation of medical and scientific to address unmet medical needs through clinical research (including observational study, database research, etc.). Job Description Primary Responsibilities + Japan CDMA Lead has extensive working knowledge of clinical development and clinical research in Japan. + Provide clinical and/or scientific input in the development and revision of core project documents (e.g., target product profile, clinical development plan, study protocol, and briefing documents related to regulatory consultation on clinical trials ). Provide clinical and/or scientific input in the development and revision of each of the core documents of the project + Confer with internal and external stakeholders and key opinion leaders to validate the clinical science component of clinical trial and clinical research. + Prepare a briefing document required for consultation with the authorities and obtain appropriate advice from the regulatory authorities. + Participate in the selection and evaluation of study sites and promote the implementation of clinical trials from an operational perspective. + Manage costs required for clinical trials (Vendor fees, research fees, etc.) and help optimize costs and resources to ensure the success of the project within budget. + Optimize in collaboration with CRO to improve development efficiency, reduce development costs, and increase development speed. + Visit study sites (hospitals, research facilities, etc.) to support the progress of clinical trials, ensure data accuracy and safety, etc. + In collaboration with the medical monitor, study lead, and others, responds to questions from study sites and monitors and guides the study from a medical perspective to ensure patient safety during the study. + Provide clinical and/or scientific input for publication activities (conference presentations, manuscript submissions) related to clinical trials and clinical research. + Support the preparation of dossier (CSR, CTD, etc.) related to regulatory filings. + Take a series of measures, such as preparing responses to inquiries from regulatory authorities arising after NDA, conducting GCP inspections, etc. Minimum requirement + A medical degree or master's degree in life sciences is preferred. Experience/Skills + At least 5 years of experience in clinical trial operations in a pharmaceutical, biotechnology or CRO company. + Basic knowledge of GCP, clinical research, regulatory requirements, project management, and knowledge of working in a matrix environment. Competency + Demonstrated ability to develop relationships and generate collaborations. + Strong analytical skills. + Solid medical/scientific writing skills required with appropriate clinical, scientific and medical knowledge to author and design and implement clinical protocol and other study documents. + Working knowledge of statistics, data analysis and data interpretation. + Ability to work independently and previous clinical experience, including the design and preparation of literature analysis, clinical protocols, clinical study reports, clinical development plans, CRFs, and other documents supporting clinical development and regulatory submissions. Ability to review and evaluate study concepts, protocols, and reports. + Written and oral communication skills in English are essential. English language to communicateskills are required smoothly, especially on matters that arise in the course of work (discussions, presentations, negotiations, etc.). with foreign countries + Organizational and cross-functional collaboration skills + Approximately 10～ 20% domestic travel required. + Proficiency in Microsoft Office (Word, Excel, SharePoint, PowerPoint, etc.). Relationship to organization/scope This position will work with multiple functions outside of clinical development, specifically Clinical Operations, Medical Affairs, and Commercial Leadership. Working Conditions Office-based At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop. Invest in your own career with Mallinckrodt and let’s do something dynamic together. Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law. Additional information on Mallinckrodt’s hiring practices may be found by clicking (https://secure.compliance360.com/ext/ESLKi3LFkqY=)