Job Title: Manager, Japan Clinical Lead
Location: Otemachi, Japan
Department: Global Clinical Development
Reports To: Senior Director, Clinical Development
Job Summary
The Japan Clinical Lead (JCL) is responsible for the clinical development strategy and execution for assigned asset(s) in Japan. This includes ensuring that clinical studies align with regulatory, scientific, quality, and medical requirements specific to Japan. The JCL oversees protocol design, study execution, data interpretation, and regulatory interactions, serving as the key clinical point of accountability for the Japan Development Team.
Key Responsibilities
1. Clinical Development Strategy & Execution
Develop and execute the Japan clinical development plan for assigned asset(s) in one or more indications.
Ensure that clinical trial designs align with global and Japan-specific regulatory and medical requirements.
Lead the scientific evaluation, interpretation, and documentation of clinical data for regulatory submissions.
Represent Clinical Development in Japan regulatory interactions, including PMDA (Pharmaceuticals and Medical Devices Agency) meetings.
2. Study Design & Oversight
Ensure global clinical study protocols align with Japan’s medical practices, making local protocol amendments as needed.
Oversee study execution, proactively identifying risks and driving mitigation strategies.
Lead the design, execution, and analysis of clinical trials, working closely with statisticians and Clinical Trial Physicians (CTPs).
Serve as the Clinical Scientist (CS) for Japan-local studies.
3. Stakeholder & Regulatory Collaboration
Act as the primary liaison between external stakeholders (e.g., Thought Leaders, Principal Investigators) to support clinical trial execution in Japan.
Represent BMS Clinical Development in both internal and external forums as a recognized authority in the disease area.
Collaborate with cross-functional teams, including regulatory, medical affairs, and commercial teams, to develop integrated disease area strategies.
4. Compliance & Data Integrity
Champion a quality-focused mindset, ensuring adherence to GCP, ICH, and compliance obligations.
Ensure the clinical program leads to a viable regulatory approval strategy in Japan.
Lead clinical content development for CSRs, regulatory submission documents, briefing books, and responses to regulatory agencies.
5. Leadership & Innovation
Guide and mentor clinical team members, fostering cross-functional collaboration.
Evaluate and propose innovative trial designs in collaboration with Japan CTPs.
Influence study prioritization and resource allocation decisions.
Required Skills & Qualifications
Education:
MD, PhD, or PharmD preferred.
Experience & Expertise:
Extensive experience (5+ years) in clinical development, preferably within the pharmaceutical or biotech industry.
Strong understanding of Japan regulatory requirements, PMDA processes, and local clinical trial operations.
Proven ability to design, implement, and analyze clinical trials.
Expertise in GCP/ICH, study design, data interpretation, and statistical methodologies.
Strong communication, negotiation, and leadership skills, with the ability to influence without direct authority.
Experience managing clinical trial risks and mitigation strategies.
Ability to synthesize internal and external clinical data to develop robust strategies.
Work Environment & Flexibility
This role is site-by-design, requiring at least 50% onsite presence at the Otemachi office.
Some travel may be required for regulatory meetings, investigator interactions, and scientific conferences.
Why Join Bristol Myers Squibb?
At BMS, we are committed to transforming patients’ lives through science. We foster an inclusive, collaborative environment that empowers employees to drive innovation and make a meaningful impact.
Apply today and become a part of a team dedicated to life-changing breakthroughs!
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