Senior Japan Project Lead

Job title:Senior Japan Project Lead

• Location: Hatsudai, Tokyo

About the Job

Job Purpose:

The Japan Sr Project Lead (Sr PL) serves as the project lead for development pipelines (with or without priority assets), holding comprehensive responsibilities with full independence. This role encompasses end-to-end responsibilities, from the early stages of development through to the product launch. The JPH will act as the project owner, aligning development strategies at both local and global levels. This includes harmonizing efforts with external stakeholders such as patients, medical societies and health authorities.

Key Responsibilities in collaboration with JP project heads accountable for the therapeutic areas:

• Strategic Development Planning: Develop a strategic development plan aligned with the Global Project Team (GPT) strategy and global financial cycle. Ensure the integration of Patients/PAG, Key Opinion Leader (KOL) and Health Authority (HA) engagement plans, as well into the operational plans. Ensure these strategies are adaptable to changing market conditions and regulatory requirements.

• Leadership and Collaboration: Lead the Japan Project Team (JPT) and co-lead the Japan Strategic Task Force (JSTF) across all development phases. Ensure alignment of project goals and strategies with key stakeholders, including senior management, cross-functional teams, GPT, and external partners. Facilitate regular communication and updates to maintain transparency and support.

• Clinical Development Strategy: Develop the clinical development strategy for Japan, including the clinical data package and clinical study protocol for local studies. Lead the decision-making process for the project, utilizing data-driven insights and scenario planning. Ensure that all decisions are documented and communicated effectively to relevant parties.

• Regulatory collaboration: Write and review clinical sections of regulatory documents, such as briefing documents for PMDA/MHLW meetings, filing dossiers for JNDA, and responses to PMDA queries. In addition to collaborate related to submission and approval, consult and support scientific and clinical contributions for health authority communications. Execute appropriate communication with regulatory agencies (PMDA/MHLW). Ensure that all project activities comply with relevant regulatory requirements and industry standards. Stay updated on changes in regulations and adjust project strategies accordingly.

• Risk Management: Identify potential risks and opportunities and develop mitigation strategies to address them. Propose scenarios and decision trees for endorsement. Regularly review and update risk management plans to ensure project continuity and success.

• Scientific Communication: Author clinical/scientific disclosures and publications for local studies and sub-analyses (Japanese/Asia). Implement the scientific communication plan.

• Partnership Building and Early Launch Readiness: Build strong, long-term partnerships with Patients/PAGs, KOLs and relevant medical societies as part of early launch readiness and excellence. The objectives of partnership include but not limited to early study/project planning, and clinical operations (feasibility and enrollment, investigator meetings, pls refer to the clinical trial support*), PMDA consultation, NDA submission, Q&A with PMDA. Ensure end-to-end launch readiness and excellence by collaborating with medical and commercial teams. Act as a business owner for development pipelines, focusing on patients/Patient Advocacy Groups (PAGs), KOLs, and medical societies.

• Process Efficiency and continuous improvement: Promote acceleration and efficiency in processes related to global strategy, e.g. GSD, GSS, resourcing strategy, and capability enhancement (e.g. DriveDigital). Promote a culture of continuous improvement within the project team. Encourage the adoption of best practices, innovative solutions, and new technologies to enhance project outcomes.

• Market Insights: Incorporate patient, KOLs, and market insights on unmet needs and the scientific/clinical value of compounds into development and submission processes through to launch.

• Resource Management: Monitor the allocation and utilization of resources, including budget, personnel, and technology. Ensure that resources are used efficiently and effectively to achieve project goals.

• Reporting and Documentation: Maintain comprehensive documentation of all project activities, decisions, and outcomes. Provide regular reports to senior management and other stakeholders to ensure accountability and transparency.

• Resource Management: Monitor the allocation and utilization of resources, including budget, personnel, and technology. Ensure that resources are used efficiently and effectively to achieve project goals.

*Clinical trial support: The Project Lead is responsible for providing comprehensive medical input and support for all activities related to clinical studies. This includes:

• Study Documents: Offering medical expertise in the creation and review of study documents, ensuring accuracy and relevance.

• Medical Training: Conducting medical training sessions for the study team to ensure they are well-informed about the study protocols and objectives.

• Feasibility Assessments: Assisting in the feasibility assessments of clinical studies to determine the practicality and potential success of the study.

• Data Review and Study Reports: Reviewing clinical data and contributing to the preparation of study reports, particularly for local studies.

• Medical Information: Providing essential medical information to the study team, medical advisors, local study managers from Clinical Study Units, and investigators to support informed decision-making.

• Collaboration with Investigators: Working closely with investigators to ensure they have the necessary medical support and information to conduct the study effectively.

About you

Key requirements

• Resource Management: Monitor the allocation and utilization of resources, including budget, personnel, and technology. Ensure that resources are used efficiently and effectively to achieve project goals.

• Comprehensive Project Experience: Extensive experience in project leadership, clinical trial operations, creation of Clinical Study Reports (CSR), filing dossiers, and Japanese New Drug Applications (J-NDAs).

• Regulatory Milestone Preparation: Proven track record in leading the preparation for PMDA/MHLW milestone meetings, including Orphan Drug designation, preP-2, EoP-2, and pre-JNDA, addressing key strategic issues.

• Interdisciplinary Understanding: Excellent understanding of the interdependencies among various disciplines such as CMC, Pharmacology/Toxicology (Pharm/Tox), Pharmacokinetics (PK), Clinical, Regulatory, Marketing, and Finance.

• Industry Experience: Minimum of 5 years of experience in drug development within the pharmaceutical, biopharmaceutical, or biotechnology sectors. Crossfunctional work experience including medical and commercial is highly preferred

• Therapeutic Area Expertise: Experience across multiple therapeutic areas, with a preference for immunology-oncology.

• Language Proficiency: Fluency in written and spoken Japanese and English.

• Digital projects experience are highly preferred

• Resource Management: Monitor the allocation and utilization of resources, including budget, personnel, and technology. Ensure that resources are used efficiently and effectively to achieve project goals.

• Influence in a Matrix Setting: Demonstrated ability to effectively communicate, influence, and lead within a matrix organizational structure.

• Collaborative Communication: Strong collaborative skills with excellent communication and negotiation abilities.

• Risk Management and Governance: Proficient knowledge and sense for risk management and governance practices.

• Performance and Outcome-Driven: Focused on achieving performance metrics and driving outcomes.

• Business/Finance Acumen and Strategic Capability: Fundamental understanding of business principles and strategic thinking.

• Innovative Mindset: Possesses scientific curiosity, logical and analytical thinking, and an innovative approach to problem-solving.

• Digital literacy: the ability to effectively and critically navigate, evaluate, and create information using a range of digital technologies. This includes, technical proficiency, information literacy, communication skills, critical thinking, and safety and security.

• Resource Management: Monitor the allocation and utilization of resources, including budget, personnel, and technology. Ensure that resources are used efficiently and effectively to achieve project goals.

• Bachelor’s Degree: A bachelor's degree or equivalent in life sciences or a related field is required.

• Advanced Degrees Preferred: Holders of a master's degree, PhD, or MD are highly preferable.

• Having clinical experience in a local medical/clinical setting is highly preferable