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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 points to consider for product development in Japan.
• Establish good working relationships with internal and external stakeholders.
• Lead the Japan Development Team (JDT) and clinical studies of the assigned project.
• Communicate closely with the GCL and Clinicians in Worldwide Research and Development (WRD) and respective Business Units (BU).
• 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 and review them if a CS is not assigned.
• Contribute to the preparation of the risk management plan for J-NDA submission and other post-approval documents.
• Review clinical data and protocol deviations and 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 in daily work and implement actions.

Requirements

• Scientific background in education.
• More than 3 years of experience in clinical development.
• Thorough understanding of processes associated with clinical and regulatory submissions.
• Skill to design and execute development strategies.
• Advanced medical and pharmaceutical knowledge.
• Knowledge on clinical study operations including guidelines and SOPs.
• Skill to think logically, innovatively, and flexibly.
• Excellent 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 composed of multiple functions.

Skills

• Clinical development
• Development strategies
• Medical knowledge
• Pharmaceutical knowledge
• 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

• Hybrid

Experience Level

• 3+ years 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.