Position Summary

Japan Program Team Lead (JPTL) is responsible for providing strategic and scientific directions on the assigned therapeutic area in Japan and leading the relivant Japan Program Team(s) managing a single indication across multiple assets. JPTL is center of KOLs and the Japanese health autholities. JPTL consults/supports clinical operational activities from medical perspective. Typically, a JPTL would conduct their JPT work as part of a GPT and under the supervision of a GPT Lead/GMT Lead. As the accountable program(s) owner, the JPTL leads and chairs the JPT, leading the creation of an integrated development/lifecycle management (LCM) plan, maintaining a strategic focus and ensuring the JPT’s commitments are met.

The JPTL’s role is one of leadership, being proactive and interactive, and emphasizing partnership with all JPT members reporting to GPTL/GMTL and other stakeholders and consultants both within and outside R&D. The JPTL should stimulate creative and productive discussion, motivate, ownership and urgency (when necessary) as well as robust discussions of risk identification and mitigation opportunities, and ensure clarity of purpose and responsibilities with the JPT. The JPTL has negotiation and persuasion skills necessary to ensure success of the program and sets goals for the JPT and specific program-related goals for the Core Team members.

The JPTL is the “one voice” for the JPT up the line (GPT, Japan R&D Leadership Team, Japan Portfolio Alignment Meeting and Alexion Management Committee), and is the principal liaison and partner to other groups.

Principal Responsibilities

The 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.
• 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 APJ senior management informed
• Is accountable for the program budget
• Ensures high performance team effectiveness

Qualifications

• 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 eight (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.
• A broad understanding of how to communicate and work well with team members and relevant people as well as scientists and external decision-makers worldwide.
• A thorough understanding of how to influence local and global regulatory, scientific and commercial environments.
• Ability to assimilate data, recognize key variables and analyze complex situations. Make quality judgments.
• A style which builds alliance within the organization, locally/globally, and/or corporate collaborators.
• Does not confuse effort for results.
• Tenacity to weather short-term setbacks for long-term advantages.
• Broad understanding of the multidisciplinary functions contributing to effective and efficient drug development.
• Has experience leading preparation of PMDA milestone meetings, such as Pre-IND, EoP-1, EoP- 2, Pre-JNDA, focusing on the key strategic issues.
• Has a firm understanding of how to educate/advise/operate with respect to Regulatory Guidances/Internal SOPs/Project best-practice behaviors.

Education

• Bachelor of pharmacology or science and/or higher with a specialty in the assigned therapeutic area, or equivalent experience with clinical development required