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メディカル・バイオ - 臨床開発リーダー・臨床開発プロジェクトマネージャー

This position is responsible for the overall development strategy of the disease project in Japan, ensuring alignment with the global project strategy as well as the Company’s R&D strategy and business objectives. The position develops and executes an integrated development plan in collaboration with global and Japan project teams—including R&D, manufacturing, commercial, regulatory, and other functions—to ensure successful product approval and launch. Input from external experts is incorporated as needed, depending on the project stage.

■休日：完全週休二日制, 土, 日, 祝日, GW, 夏季休暇, 年末年始

＜Expertise and Experiences＞
• 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.

＜Skills and Competencies＞
• 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.

＜Education and Qualifications＞
• Bachelor’s Degree: A bachelor's degree or equivalent in life sciences or a related field is required.
• Having clinical experience in a local medical/clinical setting is highly preferable.

■職種未経験者：不可