JOB SUMMARY
Clinical Development Lead drives the clinical development of assigned asset(s), contributes as Development Team Japan (DT-J) Lead, and is a representative of DT-J to internal/external stakeholders. Key Responsibilities:
• Leadership of elements of Japan clinical development programs. Development and execution of Clinical Development Plan (CDP) in collaboration with Global Asset Team or relevant Global functions
• Accountabilities as a country level for strategic design and delivery of CDP for assigned asset(s) in line with the target product profiles (TPP) and access considerations
• Optimization of studies / programs for complexity, schedule, cost, quality
• Identification of risks and assurance of mitigation plans to be implemented
• Incorporation of clinical / medical science insights into the clinical development strategy, plans and study designs
• Responsible for Japan inputs in the creation of clinical components of key documents (e.g., trial protocols, Investigator’s Brochures, CSRs, regulatory documents) and execution
• Contribution to successful regulatory filings, approvals, and launches in Japan
• Support market access, commercialization, and maintenance of product licenses for assigned asset(s)
Major Accountabilities:
• Collaboration: Maintain excellent working relationships within teams and internal stakeholders (e.g., Medical Affairs, Commercial, Pharmacovigilance) to meet objectives. Well contributed and engaged global Asset Team and relevant global functions
• Strategy: Provide Japan input and contribute to the development and revisions of CDPs, ensuring alignment with TPP
• Regulatory Submissions: Contribute to clinical components of regulatory submissions in Japan including development of briefing book and answers for questions from HA, ensuring timely delivery
• External Collaboration: As the medical / scientific expert, develop and manage a network of Japan external stakeholders (e.g., regulatory authorities, key opinion leaders, patient advocacy groups)
• Compliance: Ensure program compliance with regulations, SOPs, and quality standards.
• Knowledge Sharing: Share clinical program knowledge across the organization and ensure lessons learned are applied to future programs


MAJOR ACCOUNTABILITIES Describe the main accountabilities for this role including significant tasks, responsibilities and projects
1. Accountable for the comprehensive Japan clinical development programs and studies for assigned asset(s) and applicable indications
a. Accountable and responsible to develop and manage a network of Japan external experts to collect disease and patient unmet need insights that inform clinical development strategy
b. Responsible for providing Japan inputs, defending and updating clinical development plan (CDP) / clinical study design for each indication for the assigned asset, in line with TPP and Japan regulatory (post-approval) requirements in collaboration with Global Asset Team or relevant Global functions
c. Responsible for integrating up-to-date scientific/medical, statistical, Japanese regulatory/HTA, patient and clinical operations insights into a fit-for-purpose CDP/study concept/study protocol considering reduction of overall protocol complexity
d. Accountable for overseeing the ongoing evaluation of study efficacy/safety and data quality, effectively and efficiently interact with partners, key opinion leaders and investigators
e. Accountable for the ongoing evaluation of the benefit/risk ratio of the compound at asset and indication level
f. Accountable for result interpretation (RIM) and reporting (CSR)
2. Responsible to lead Japan Development Team (DT-J) assigned asset(s) in a matrix organization
3. Responsible to lead the clinical team in the planning and timely execution of high quality clinical components of regulatory submissions for the indication(s)/formulation(s); contributes to the development and finalization of Japan clinical submission documents
4. Responsible to present and justify Japan clinical development strategic position and plan to internal (Governance bodies at program and study level) and external stakeholders (Regulatory Authorities, strategic partners)
5. Responsible for providing drug development and therapeutic expertise to Business Development by contributing to the evaluation of licensing-in compounds
6. Responsible to present at conferences, symposia, and meetings with Japan Investigators and Key Opinion Leaders within the scope of the role
7. Accountable for audit/inspection readiness and overall compliance with regulations (eg, ICH GCP) in Japan and applicable quality standards at all times