Overview As a Senior CMC Global Project Manager, you will lead cross-functional CMC subteams to develop and execute strategic CMC roadmaps across assets. You’ll partner with the CMC Lead and Asset Operations Lead to drive integrated plans, budgets, and governance, ensuring timely, on-budget delivery. You’ll mentor teams, manage risk, and enable effective communication with senior stakeholders. This role sits at the heart of Ipsen’s Asset Team to maximize patient value and streamline development programs.
Responsibilities - Serve as the central operational point for CMC, subteams, and Asset Team members
- Create and maintain asset CMC roadmap aligned with asset strategy
- Develop and maintain CMC project plans with interdependencies across functions
- Lead cross-functional monthly CMC operations meetings and monitor execution
- Manage budgets, resources, and governance communications; escalate issues with mitigation plans
- Apply consistent risk management and identify contingencies for project delivery
- Support vendor selection and management as needed
- Ensure compliance with GxP, regulatory requirements, and quality systems
- Capture lessons learned and benchmark against competitors to drive improvement
- Provide leadership, mentorship, and cross-functional collaboration across regulatory, manufacturing, formulation, analytics, quality, and supply
Key requirements - 8-10+ years in Pharmaceutical/Biotech with CMC development experience
- Demonstrated leadership of cross-functional drug development operations
- Strong budgeting, resource forecasting, and cost control abilities
- Excellent communication, stakeholder management, and negotiation skills
- Proficiency in cross-functional project leadership in fast-paced environments
- Knowledge of regulatory submissions and compliance knowledge (preferred)
- Experience with project management tools and data-driven decision making
- collaboration
- leadership
- communication
- Microsoft Project
- Microsoft Office
- PMO tools
