Associate Medical Director, Clinical Science Immunology

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.

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.

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

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.

#LI-Hybrid

========================================================

社内公募ガイドライン

• 応募の際はAskGS内の社内公募ガイドラインをご一読いただき、応募ください。 か月未満の方は応募前に上長及び担当BUHRの許可を取ってから応募ください。複数同時応募不可になります。




• 在籍期間に関わらず、書類選考を通して 次面接に進んだ場合は、社内公募に応募し選考に進むことを上司に報告してください。




• 社内紹介を行う場合は、Career Hub上の“社内紹介制度の概要”の詳細を理解した上で、コンプライアンスを守っ て紹介したものとみなします。

Required Skills:

Preferred Skills:

• Sign In
• Create Account

Sign in

To continue your application

Sign in with Google

Sign in with Linkedin

---

or continue with email

Email address

Password

Forgot your password?

Resume or CV

Improve your chances of getting an interview

Drag & drop or browse

.pdf, .doc, .docx (Max 10MB)

Continue →

By continuing you agree to our Terms & Privacy Policy.