Job Title: Japan Portfolio Project Lead Function: R&D Project Leadership / Development Strategy Scope: Japan, with Global Project Ownership Role Overview A global pharmaceutical organization is seeking a Japan Portfolio Project Lead to act as the end-to-end owner of development pipelines in Japan, from early development through approval and launch. This role holds full accountability for Japan development strategy, execution, and decision-making, operating with a high degree of independence while aligning closely with Global Project Teams and senior stakeholders. The position integrates clinical, regulatory, scientific, and business perspectives to ensure successful delivery of complex development programs. Key Responsibilities
Own Japan development strategy aligned with global project and financial cycles
Lead Japan Project Teams and co-lead Japan Strategic Task Forces
Develop and execute Japan-specific clinical development strategies and data packages
Lead PMDA/MHLW interactions, including preparation of briefing documents, filings, and responses
Drive risk identification, scenario planning, and mitigation strategies
Act as business owner for development pipelines, incorporating patient, KOL, and market insights
Ensure early launch readiness through strong collaboration with medical and commercial teams
Manage project budgets, resources, and timelines
Author and oversee scientific communications and publications for local studies
Serve as an ambassador for Japan R&D across the organization
Required Experience & Skills
Strong experience leading complex drug development projects in Japan
Deep understanding of regulatory, clinical, CMC, and commercial interdependencies
Proven ability to influence and lead in matrix organizations