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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Chiyoda, Tokyo, Japan

Job Description:

JOB SUMMARY:

Associate Medical Director (AMD) assumes the role of Japan Study Responsible Physician (SRP) and is accountable for medical decision-making required to support and execute assigned global, regional, and local studies from the initiation through close-out, in close collaboration with Japan Clinical Lead (JCL) and Japan Clinical Scientist (JCS), and relevant study teams. AMD serves as a local delegate of the global SRP and provides medical-related support for Japanese participants in relevant global studies, as needed. Depending on business needs, AMD may also provide medical support for assigned global studies, including regional responsibilities across East Asia/APAC, in collaboration with relevant study teams.

AMD is responsible for developing and implementing medical review plans, ensuring subject safety, protocol compliance through eligibility review, ongoing medical data review, and resolution of medical queries. AMD also appropriately shares medical knowledge and insights gained from assigned studies with relevant stakeholders.

AMD provides medical consultation to internal stakeholders to support scientifically sound & unbiased data interpretation and delivers medical advice and training to members of TA IMM Clinical Development and other relevant functions.

KEY RESPONSIBILITIES:

[Medical Responsibility for assigned global, regional, and local studies]

• Provide medical-related support for Japanese participants and assigned regional responsibilities within global studies, including East Asia/APAC countries, as needed.

• Respond to medical-related queries regarding eligibility criteria, protocol interpretation, and study conduct.

• Respond to safety-related inquiries from health authorities or study sites through appropriate documentation or other communication methods (e.g. e-mail, meetings, site visits, etc.).

• Be accountable for the medical content of study-related documents through signature responsibility.

• Maintain a thorough understanding of relevant disease backgrounds, including patient characteristics and available treatment options, based on the latest scientific and clinical information, and through interaction with external experts when necessary.

• Provide medical knowledge and insights acquired through assigned studies to study team members.

• Contribute to the design of local/regional studies from a medical perspective and participate in study initiation activities in collaboration with SRS.

• Develop medical review plans, share them with relevant members, and execute medical reviews, including protocol deviation assessments, particularly for safety-related matters.

• Review and approve study-related documents, including informed consent forms, major protocol deviation criteria, database release plans, major protocol deviation listings, etc.

• Participate in activities related to database lock, results presentation, preparation of Clinical Study Report (CSRs), and publications as a subject matter expert (SME).

• Serve as a member of the Study Evaluation Team (SET).

[Provide medical advice and training]

• Provide medical opinions and propose appropriate actions for medical matters upon request from members of the Clinical Development Division or other functions.
• Execute medical-related consultation for internal stakeholders to ensure scientifically sound and unbiased interpretation of clinical data.

• Periodically provide training on selected topics to enhance the understanding of roles in clinical and operational divisions, enabling other functions to manage defined medical-related issues more independently.

REQUIREMENTS:

Experience/Knowledge

• At least 5 years of clinical experience is preferred.

• Working experience in pharmaceutical company is essential.

• Knowledge of clinical development and clinical trial design required to support appropriate medical decision-making in a pharmaceutical research setting.

• Adequate work experience in clinical practice and/or clinical research are required.
• Understanding of and compliance with healthcare regulations, guidelines, and medical ethics is preferred.

Skills/Capabilities

• Strong scientific and logical thinking with the ability to make sound and balanced medical decisions, considering implications for clinical development across multiple diseases.
• Ability to rapidly understand and grasp new diseases or mechanisms of action.
• Ability to collaborate effectively with cross-functional teams, representing the medical perspective while maintaining a balanced view.
• Understanding of regulatory science and safety risk management.
• Ability to consistently demonstrate stable performance while managing multiple tasks in parallel.
• Strong oral and written communication skills in both Japanese and English.
• Ability to work effectively in global and regional study settings across time zones and cultures, and to align local/regional medical needs with global study governance and decision-making frameworks.

Qualification/Certificate

• MD (or equivalent) is required.

 

 

Required Skills:

 

 

Preferred Skills:

Clinical Research and Regulations, Clinical Trials, Clinical Trials Operations, Collaboration, Consulting, Data Management and Informatics, Drug Discovery Development, Industry Analysis, Innovation, Leadership, Market Research, Regulatory Affairs Management, Research Ethics, Scientific Evaluation, Scientific Research, Stakeholder Management, Tactical Planning, Technical Credibility