Pharmaceutical Project Management (PPM)/Manager・Sr Manager/神戸本社/Lilly社員のみ東京可

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.  Pharmaceutical Project Management (PPM) PURPOSE: The purpose of Pharmaceutical Project Management (PPM) role is to have overall responsibilities for working with the leadership of the Global counterparts and the corresponding Affiliate Business Unit functions to assure development and implementation of appropriate pharmaceutical development strategies and plans from early-phase to end of the lifecycle of the molecule on time and on budget in the relevant therapeutic area.  The key deliverables are full portfolio coverage, simultaneous development and launches, and creating value across the entire product life stage.  The role will be assigned to one or more Therapeutic Areas (Immunology, Neuroscience, CMH or Oncology).

1.  Align the Portfolio, Development to BU Strategies Engage Medical, Clinical, Regulatory, CMC/Manufacturing, Marketing, Safety Functions and other functions to deliver the portfolio and align drug development strategies with BU strategies. Provide leadership for development of Product Lifecycle Plan in alignment with the Therapeutic Area development and commercial strategies. Deliver necessary information and data about the new/ongoing projects for the portfolio and business plan management.   2.  Lead Value Maximization Through Product Lifecycle Lead to develop robust Japan Project Plan that fortifies linkages to Asset Profile, Value proposition, MMFA (Manufactured Marketed Forms Agreement) and scope, assures quality and consistency of content, and translates into operational objectives. Translate Japan marketing, medical and regulatory needs for the molecule/new indication/line extension (including new formulation / delivery solution) into the global integrated plan. Lead overall launch readiness and co-lead the affiliate overall launch readiness in collaboration with respective commercial leader. Ensure post-marketing activities including issue management are managed well by providing leadership to cross-functional collaboration.   3.  Deliver Results Lead the team to meet or exceed overall project goals (completion of clinical studies, CMC deliverables and NDA/device preparation, submission and approval timing, etc.) Deliver project milestones on time, on budget, within scope, and to high quality standards by holding functions accountable for achievement of key project deliverables in alignment with the agreed to project plan and in compliance with Japan quality standards. Identify areas for where process improvement will enable better results and work with discipline leaders to impact change.   4.  Apply Project Management Knowledge and Processes             Work with Japan governance to authorize project scope and plans. Scope and plans should be based on broad scenario planning, robust risk management planning, and reliable execution (timeline, FTE, and budget) planning which ensures all functional requirements are appropriately reflected. Develop and implement stakeholder, global, and team communication plan to ensure alignment with medical affairs strategy and product development strategy.   Lead external communication strategy related to development (e.g. data read outs, regulatory outcomes).  Provide rapid and quality responses to external customers. Monitor and control performance of the overall project