Japan Program Team Lead, Director, R&D Division

Responsibilities

• Hold ultimate responsibility for defining goals, plans, decision-making, and deliverables for R&D programs in the Japanese market.
• Set and drive program direction in the Japanese market based on global strategies, including development and LCM strategy planning.
• Manage the execution of program plans and ensure the achievement of critical milestones.
• Oversee all relevant activities from development start through lifecycle management, including preclinical, CMC, clinical, and LCM.
• Lead the Japan Program Team (JPT) to review and improve program plans.
• Manage program budgets and contribute to goal setting and core member evaluations.
• Collaborate with and mentor other JPTLs to maximize team effectiveness.

Requirements

• 10+ years of drug development experience in the pharmaceutical, biopharmaceutical, or biotechnology sectors.
• Proven project management experience in clinical trials (including CTN).
• Extensive experience with J-NDA applications and PMDA consultation/milestone meetings.
• Bachelor's degree in Pharmacy, Science, or an equivalent field.
• Experience leading drug development projects within a global and matrixed organization.
• Strong understanding of cross-functional requirements including CMC, pharmacology/toxicology, PK, and regulatory submissions.

About the Company

Alexion is a leading biopharmaceutical company focused on delivering life-changing therapies for people with rare diseases. As part of AstraZeneca, we are committed to fostering a culture of belonging and scientific excellence to transform the lives of patients worldwide.