- 非公開 No.AD192007
- ・Lead the project management for outsourced global projects with multiple work streams (drug substance, drug product, logistics, etc.) and integrate implications for any external operations opportunities.
・Accountable for assessment and evaluation of CMO and vendor capabilities critical for successful delivery of our company's clinical development portfolio, in partnership with PS Functional SMEs.
・Act as an operational liaison between Clinical Supply Chain and stakeholders, our company partners, and contract manufacturing organizations. Effectively engage with key stakeholders (internal and external) to ensure timely implementation of project objectives. Identify interdependencies and connections between departments and ensure integrated end to end visibility and alignment.
・Provide a single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CMO governance structure.
・Demonstrate an understanding of company priorities, objectives and project timelines. Define and manage critical path, proactively identify and escalate issues and help resolve them.
・Develop and manage mutually beneficial, long-term business relationships with CMOs.
・Demonstrate strategic thought and resource planning to support multi-geographic programs and personnel.
・Identify and communicate opportunities for change; plans for team to meet new challenges.
・Lead and support Clinical Supply Chain business initiatives and facilitate their implementation with appropriate stakeholders
・BS and 10+ years experience or advanced degree and 8+ years of experience.
・Must have exceptional working knowledge of CMC operations relating to research and development and investigational drug manufacturing. Must have direct management experience with external contract manufacturing organizations.
・Demonstrated excellence in project management and effectively managing multiple projects/priorities.
・Experience implementing systems and processes for support of cross-functional activities.
・Must have strong PC experience along with expert in MS Office suite applications.
・Able to troubleshoot critical issues or problems and resolve routine issues using appropriate information.
・Ability to work well in a cross functional team environment, build consensus and drive resolution of issues while maintaining positive working relationships across functions.
・Exceptional oral and written communications skills with the capacity to present effectively to a diverse range of audiences.
・Exercises exceptional time management skills and is able to successfully manage multiple tasks simultaneously.
・Demonstrate a high degree of self-awareness, self-motivation, initiative, and attention to detail.