Tokyo,12.0M ～ 16.0M
- Responsible for leading the relevant Japan development team (called ‘Japan Evidence Generation Team’, JEGT), and developing an integrated Japan development plan incorporating local current medical/clinical insights into specific molecules in accordance with global development strategy.
- Contribute medical/clinical expertise to advancing our pipeline Responsibilities include,
- As the lead of the JEGT, appropriately share Global EGT strategies to the JEGT members, indicate strategic direction of JEGT in accordance with global strategy and ensure that Japan product strategies are based on multifaceted considerations aiming to maximize values for patients and Amgen.
- As the lead of JEGT, encourage active and efficient work styles in accordance with the Team Charter and build an environment where each member can utilize their full potential
- Provide deep local medical/clinical and scientific (as applicable) insights to local and global product teams
- Partner with Regulatory Affairs to facilitate local registration by providing medical/scientific leadership and input into key regulatory deliverables, i.e. CTD, Regulatory responses, etc.
- Partner with study teams and operation teams to ensure timely study delivery.
- Support the Medical Affairs in capturing and translating local data gaps into actionable evidence generation plans (EGPs), in alignment with global product strategy and global EGP.
- As the clinical expert on the product, communicate the total evidence and biologic insights with internal stakeholders to align and inform their strategies, and with external stakeholders (KOLs / investigators, regulators, and payers) to shape the practice of medicine