This position is responsible for providing leadership for China CMC activity of the portfolio both chemical drug and biological drug as a director of CMC management in China. This positionis also responsible for the on-time delivery of China clinical supplies for programs with significant technical and geographic complexity across the Daiichi Sankyo portfolio.
This individual will be to provide strategic management of high complexity teams and drive the execution of China CMC development through CMC team meeting management, leading strategic CMC development planning aligned with global CMC strategy, timeline management, stakeholder management, risk/issue management, finance and resource management, and conflict resolution as a director of CMC management.
1.CMC Team management
From an overall optimum point of view and deep CMC-related knowledge, formulate clear CMC strategies (communicate well to CMC Team members). Consider the development of Plan B from the perspective of risk management. At the onset of the task, take a proactive role in solving the task.2. Regulatory Affairs
Work with RACMC to schedule regulatory affairs-related CMC tasks for clinical trial application. Collaborate with RACMC to coordinate the content and timing of consultation to authority. As one of reviews, confirm whether the requirements are appropriately reflected in the materials related to approval applications
(IND, NDA, inquiry response, etc.).
3. Coordinationand cooperation within and outside the DSCN PT division
As a representative of the CMC/CSO related tasks in DSCN PT, participate in the PJ team to accurately assess the PJ status and to provide appropriate solutions to any issues through close communication with
global PT members and China local members. Provide necessary PJ information to CMC Team members, seniors, and other stakeholders within the DSCN PT, and lead discussions on CMC issues and decisions on strategies within the DSCN PT.
4.Investigational medicinal product supply management
Planning, conflict management, and risk control of supply chain management of investigational medicinal products with no delay in China clinical trials and China MA studies.