技能/経験

■Basic Qualification
Knowledge, Skills & Experience
1.           Japanese medical license (MD)
2.           Clinical development experience in the pharmaceutical or vaccine industry (ideally 3–5+ years), or experience in clinical research.
3.           Demonstrated experience interacting with Japanese regulators (PMDA/MHLW) and local stakeholders.
4.           Proven ability to lead cross functional, matrixed teams and make high impact decisions.
5.           Track record in clinical strategy development, study design, and benefit–risk assessment.
6.           Strategic and scientific leadership with strong therapeutic/asset expertise.
7.           Excellent stakeholder management, negotiation and influencing skills.
8.           Strong problem solving, risk management and decision making capability.
9.           Operational delivery focus with attention to quality and compliance.
10.          Coaching and people development skills; ability to build high performing teams.
11.          Familiarity with innovative clinical trial design and digital/remote approaches.
12.          Fluent in Japanese and business level English (speaking and writing).
※日本での就労資格を有すること。/ Legal right to work in Japan.

スキル
Glowth Mindset, アジャイル思考, コミュニケーション, コラボレーションの促進, チームワーク, チェンジ マネジメント, ビジネス コーチング, プロジェクト管理, マトリクス リーダーシップ, 権力を伴わない影響力, 臨床開発, 臨床研究, 臨床試験管理システム (CTMS)

■Preferred Qualification
Success measures / KPIs
• On time delivery of Japan clinical milestones (studies initiated, enrolment, submissions).
• Quality of regulatory interactions and acceptance of clinical part of Japan submissions.
• Alignment and integration of Japan clinical strategy with global strategy.
• Team capability growth and retention; successful mentoring of CSs and other team members.
• Demonstrated adoption of innovative approaches that improve timelines or value.
• Establishment of peer-to-peer relationship with a counter global CDL
Additional Information
Travel: occasional domestic and international travel as required for regulatory meetings, investigator sites and conferences.
This role operates in a matrixed environment and will require close collaboration with global MDT/VDT and cross functional Japan teams.

Skills
Agile Thinking, Clinical Development, Clinical Trial Designs, Decision Making, Fostering Collaboration, Influencing Without Authority, Leadership, Matrix Leadership, Mentorship, People Management, Project Management, Risk Management, Strategic Thinking, Teamwork, Time Management​‌