Job Summary

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.

Responsibilities

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.

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.

Qualifications:

• Master’s degree in Life Science or Pharmacy, PhD preferred; Program Management certification is a strong plus.
• Minimum of 5-10 years of experience in thepharmaceutical industry, and minimum of 5 years of experience in global CMC project manager and/or project manager with emphasis on late-stage CMC drug development on chemical drug and/or biologics in China (at least 2 years of experience in CMC project manager).
• Strong technical experience with exposure to pharmaceutical, biotech industries CMC product development is highly preferred.
• Communication: Sharing information and knowledge with other CMC managers, conversations (how to talk), emails, listening, English, adjust, negotiation, appeal, and presentations. Excellent written and oral communication skills in English
• Knowledge: Drug substance, Drug product, Analytical method development, Import etc.  Development, approval application, and marketing process in China.  Basic; IT-related; contracting; patent; accountability and financial management; management perspective
• Management Leadership: CMC team steering (timeline, budgeting); shared vision, motivations, and involvement of person concerned; challenge and risk extraction; task solving and plan B formulation; strategy decisions; team building.  Coordination with seniors: team policies, member resources, flexibility, leadership, autonomy, and independence.  Education, guidance, and coaching for CMC team members
• Self-management: Controlling ‘Emotional Intelligence’ and feelings; stress tolerance; time management; heightened mindfulness and motivation; challenging spirit
• Leadership: Experienced in supervising, coaching, motivating, training and mentoring junior staff members including effective work delegation.

Contact: Dennis