Associate Medical Director, Clinical Science Immunology

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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 Directo r (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 interp retation, 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 docume...