Jobs in Japan
Explore hand-picked jobs in Japan for English speakers across tech, education, marketing, and more.
Vetted companies only. Apply from overseas.
Explore hand-picked jobs in Japan for English speakers across tech, education, marketing, and more.
Vetted companies only. Apply from overseas.
Responsible for clinical development of the assigned project in Japan under the supervision of the Japan Development Leader (JDL), who assumes responsibility for development of all projects in Japan in the respective therapeutic/disease area (TA/DA). Exercises proactive leadership in the project and obtains approval in Japan. Works with the Global Clinical Leader (GCL) and Clinicians to formulate and execute the global and Japan development strategies of the project. Evaluate candidates for development in the assigned TA/DA from scientific and technical aspects and formulate an effective development plan for Japan with the JDL and the global team. Contribute to establishing the global development plan by discussing points to consider in developing the product (including biomarkers and diagnostics) and obtaining approval in Japan (e.g. medical practice, communication with the government) with the global team and considering strategies towards early launch. Establish good working relationships with internal and external stakeholders [e.g. key opinion leaders (KOL), academic society, patient group] to enhance the possibility of expedited development and early approval with the JDL and senior JCL. Lead Japan Development Team (JDT) and clinical studies of assigned project to success in cooperation with JDT and global team members. Communicate closely with the GCL and Clinicians in Worldwide Research and Development (WRD) and respective Business Units (BU) and build and execute an effective development strategy. Prepare high quality documents (e.g.study outline, briefing document, CTD, query response, publications) and review them. When a Clinical Scientist (CS) is assigned to the project, review the documents prepared by the CS (e.g. full protocol, informed consent document, investigator's brochure); when a CS is not assigned, the JCL is responsible to prepare and review these documents. Contribute to the preparation of the risk management plan for J-NDA submission and other documents required after approval. Review clinical data and protocol deviations and determine necessary actions for clinical studies in which he/she is the Clinical Lead. Review individual subject and cumulative safety data based on the safety review plan. Lead preparation of procedures related to independent data monitoring committee (IDMC), adjudication committee (AC), and safety review committee, and manage and execute the committees. Continuously seek opportunities for improvement in daily work and propose and implement actions without being ruled by conventional work habits.
- Scientific background in education, >3 years or more experience in clinical development - Experience in clinical development; thorough understanding of the processes associated with clinical and regulatory submissions - Skill to design and execute development strategies (e.g. advanced medical and pharmaceutical knowledge, skill to design development strategies, knowledge on clinical study operations including guidelines and SOPs, skill to think logically, innovatively, and flexibly, writing skills) - Leadership skills - Team building skills, networking skills - Negotiation skills, consensus building skills - Problem solving skills - Project management skills - Excellent writing and communication skills in both Japanese and English - Presentation skills, logical and scientific expertise to discuss with internal/external and Japanese/global stakeholders
- Sustained delivery and innovation within the discipline - Sustained contribution to the pharmaceutical R&D process at the study level - Proven ability to contribute to multiple projects - Successful management of medium-sized teams consisted by multiple functions
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business. Our Competitive Benefits Programs help our colleagues by: Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more. Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals. Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs. And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.