募集要項
- 仕事内容
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Japan Program Team Lead (JPTL) :
• Is accountable for Program ownership in Japan with final accountability for clear definitions of program goals, plans, decisions and deliverables to meet those goals
• Provides strategic direction and leadership in Japan for assigned programs in accordance with the global strategy.
• Provides development/LCM strategy and leadership for assigned programs to ensure clear goal setting and robust development/LCM plans for effective and efficient program management.
• Ensures that the JPT implements its plans and adheres to key milestones for assigned programs.
• Is accountable for aspects of pre-clinical, CMC, clinical, LCM plans and programs across from initiation of the development in Japan through LCM.
• Leads the JPT and reviews plans for assigned programs.
• Contributes to objective setting and appraisal of core team members for program related activities
• Keeps senior management informed
• Is accountable for Program budget
etc.
- 応募資格
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- 必須
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• Total leadership experience including project management which includes leadership in more than one CTN, clinical trial management, CSR/CTD creations, J-NDA, PMDA Consultation is desirable.
• Minimum of 8 years of experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology.
• Demonstrated experience leading the development of at least one development candidate with adherence to quality, excellence and efficiency.
• Demonstrated experience leading drug development projects and activities in a matrixed, global organization.
• Has experience leading preparation of PMDA milestone meetings, such as Pre-IND, EoP-1, EoP- 2, Pre-JNDA
• Has a firm understanding of how to educate/advise/operate with respect to Regulatory Guidance/Internal SOPs/Project best-practice behaviors
- 雇用形態
- 正社員
- 勤務地
- 東京都
- 年収・給与
- 想定年収：1500万円～1800万円程度（応相談）※ご経験・スキルに応じて検討します。
- 待遇・福利厚生
- Social insurance
- 休日休暇
- Full 2 holiday week system (Sat/Sun) national holidays, New year’s holiday, Annual Leave
