CMC Strategy Lead
6 days ago
The CMC Product Lead is a critical strategic position within the CMC organization, responsible for overseeing and executing CMC strategies for multiple assets across therapeutic areas from first in human to pivotal studies. This role ensures seamless integration of program strategy with the Target Product Profile (TPP) and Quality Target Product Profile (QTPP), and is accountable for translating Core Team strategies into actionable CMC plans.
Key Responsibilities- Define and Communicate Strategic CMC Development Plans
- Translate Core Team strategy into actionable, achievable CMC tasks and milestones, prioritizing the portfolio in alignment with enterprise priorities.
- Serve as a key member of Core Team, representing CMC and working under the guidance of the Leadership Team (LT).
- Act as the primary point of accountability for the CMC plan, making critical decisions and serving as a resource to key leadership.
- Engage in technical discussions, own technical roadmap for program implementation and contribute to CMC sections of global regulatory submissions.
- Lead CMC team in discussions with key leadership, R&D teams, and internal governance bodies.
- Identify and address cross-functional gaps and risks, escalating issues appropriately to drive progress.
- Accountable for the strategy of the resource and financial management of the team, including budgeting, resource allocation and cost management.
- Empower and delegate to team members/workstream leads, establishing credibility by diving into the appropriate level of detail when necessary.
- Build and maintain strong relationships across the organization, including with cross-functional stakeholders for facilitating strategic handshakes for effective lifecycle management.
- MS with a minimum of 10 years, or BS/BA with a minimum of 12 years of relevant experience.
- Strong knowledge of CMC-related activities, including Technical Development, Manufacturing, Supply Chain, Quality, Process Development, and CMC Regulatory.
- Able to work cross-functionally with R&D, Clinical Development, and Commercial teams.
- This role is based in a dynamic and innovative environment and is expected to be in office 70% of the time with flexibility to work from home up to 30%.
- PhD in relevant field such as Biochemistry, Chemistry, Biology, Pharmaceutical Sciences.
- Demonstrates sufficient technical depth in drug development to inform overall CMC strategy.
- Financial/business acumen and executive influence with strong stakeholder management skills at all levels.
- Demonstrates leadership quality, poise, flexibility, adaptability, and superb written and verbal communication skills.
- Cross-functional influence, negotiation skills, and a champion of effective decision-making processes.
- Considered a thought leader in program strategy and tactics with the ability to operate through complex and ambiguous situations.
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Lead Manager, Global Regulatory Affairs CMC
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Product Development Director
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