Associate Director, CMC Program Management Lead
4 weeks ago
We are seeking an experienced Associate Director to lead our CMC Program Management team in Technical Development. The ideal candidate will have a strong background in science and prior experience in Manufacturing, Quality, Process Development, and/or Supply Chain organizations.
The Associate Director will be responsible for leading pivotal work focusing on the design and comprehensive management of CMC program integrated project plans. This includes aligning priorities for optimal project execution, managing and leading teams in drug discovery/development projects, and ensuring seamless execution and management of program(s).
The successful candidate will have excellent communication skills, the ability to influence without authority, and a proven track record of leading cross-functional teams or projects characterized by complexity, risk, and integration requirements across multiple functions.
Key Responsibilities
- Leverage previous experience within CMC product development and commercialization to integrate between multiple functional areas, including Tech Dev, Manufacturing, Regulatory, Quality, and Supply Chain.
- Lead cross-functional teams or projects characterized by complexity, risk, and integration requirements across multiple functions, ensuring adherence to broader organizational goals.
- Influence high-level decision-making within the organization by providing comprehensive project insights and strategic recommendations.
- Oversee the CMC project plan to align with strategic goals and ensure timely execution.
- Develop project plans that integrate cross-functional inputs and support strategy execution.
- Manage risk registers by identifying risks and implementing mitigation strategies.
- Ensure action items from team meetings are completed, upholding team accountability.
- Organize and lead team meetings, producing concise materials to communicate key points.
- Provide data analysis to support strategic decisions and direction setting.
- Track project milestones, report progress, and keep stakeholders informed.
- Formulate plans for risk mitigation and scenario planning for potential challenges.
- Oversee project budgets, ensuring alignment with financial objectives.
- Lead Project Management processes, including reviews, goal setting, and commercialization strategies.
- Drive the enhancement of Project Management practices for organizational effectiveness.
- Advocate for resources to impact long-term organizational objectives, effectively managing external vendors and ensuring alignment with organizational standards.
- Participate in and contribute to company-wide improvement initiatives.
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