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About the Role
Responsible for the clinical development of assigned projects in Japan, working under the Japan Development Leader (JDL) and collaborating with the Global Clinical Leader (GCL) and Clinicians to formulate and execute global and Japan development strategies.
Responsibilities
- Evaluate candidates for development from scientific and technical aspects.
- Formulate an effective development plan for Japan with the JDL and global team.
- Contribute to establishing the global development plan by discussing development considerations and approval strategies for Japan.
- Establish good working relationships with internal and external stakeholders to enhance expedited development and early approval.
- Lead the Japan Development Team (JDT) and clinical studies to success.
- Communicate closely with the GCL and Clinicians to build and execute an effective development strategy.
- Prepare and review high-quality documents, including study outlines, briefing documents, CTD, query responses, and publications.
- Review documents prepared by Clinical Scientists (CS) or prepare/review them if a CS is not assigned.
- Contribute to the preparation of the risk management plan for J-NDA submission and post-approval documents.
- Review clinical data and protocol deviations to determine necessary actions for clinical studies.
- Review individual subject and cumulative safety data based on the safety review plan.
- Lead the preparation and execution of procedures for independent data monitoring committees (IDMC), adjudication committees (AC), and safety review committees.
- Continuously seek opportunities for improvement and implement actions.
Requirements
- Scientific background with over 3 years of experience in clinical development.
- Thorough understanding of clinical and regulatory submission processes.
- Ability to design and execute development strategies.
- Knowledge of clinical study operations, including guidelines and SOPs.
- Logical, innovative, and flexible thinking skills.
- Excellent writing skills.
- Leadership skills.
- Team building skills.
- Networking skills.
- Negotiation and 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 composed of multiple functions.
Skills
- Clinical development
- Clinical and regulatory submissions
- Development strategy design and execution
- Clinical study operations
- Guidelines and SOPs
- Logical thinking
- Innovative thinking
- Flexible thinking
- Writing
- Leadership
- Team building
- Networking
- Negotiation
- Consensus building
- Problem solving
- Project management
- Communication (Japanese and English)
- Presentation
- Scientific expertise
Location
- Japan
Work Type
- Full-time
Experience Level
- 3+ years of experience in clinical development
Education Level
- Scientific background
About the Company
- Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
Equal Opportunity
- Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
- To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.