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Japan Portfolio Project Lead

仕事詳細

勤務地: 日本
給与: ¥6000000 - ¥25000000 per annum
職種: 正社員
専門: 製薬・メディカルディバイス
参照: 57514
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
  • Strong business, financial, and strategic acumen
  • Fluent Japanese and English communication skills
Education
  • Bachelor’s degree in life sciences required
  • Master’s, PhD, or MD strongly preferred
 

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