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About the Role

The Associate Medical Director (AMD) serves as the Japan Study Responsible Physician (SRP), leading medical decision-making for assigned global, regional, and local studies. This role ensures subject safety, protocol compliance, and provides medical consultation to internal stakeholders, contributing to scientifically sound data interpretation and training.

Responsibilities

• Provide medical-related support for Japanese participants and assigned regional responsibilities within global studies, including East Asia/APAC countries.
• Respond to medical-related queries regarding eligibility criteria, protocol interpretation, and study conduct.
• Respond to safety-related inquiries from health authorities or study sites.
• Be accountable for the medical content of study-related documents through signature responsibility.
• Maintain a thorough understanding of relevant disease backgrounds, patient characteristics, and treatment options.
• 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.
• Develop and execute medical review plans, 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, and major protocol deviation listings.
• Participate in activities related to database lock, results presentation, preparation of Clinical Study Reports (CSRs), and publications as a subject matter expert (SME).
• Serve as a member of the Study Evaluation Team (SET).
• Provide medical opinions and propose appropriate actions for medical matters upon request.
• 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 understanding of roles in clinical and operational divisions.

Requirements

• At least 5 years of clinical experience is preferred.
• Working experience in a 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.
• 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.

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

Location

• Chiyoda, Tokyo, Japan

Work Type

• Full-time

Experience Level

• 5+ years clinical experience preferred

Education Level

• MD (or equivalent) is required

About the Company

• At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

Equal Opportunity

• As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.