- Own and drive the end-to-end CMC strategy across development, clinical supply, scale-up, and commercialization for a portfolio of small-molecule programs
- Operate with a high degree of independence and accountability, proactively identifying risks, tradeoffs, and opportunities across the CMC landscape
- Anticipate CMC challenges well in advance and lead structured problem-solving efforts, balancing speed, quality, cost, and regulatory expectations
- Build scalable CMC roadmaps aligned with clinical milestones, financing events, and long-term corporate strategy
- Define CMC organizational requirements and ensure corporate objectives are delivered through internal and external resources
- Select, manage, and hold CROs, CDMOs, and consultants accountable for performance, quality, and timelines
- Develop and manage CMC budget
- Support business development and evaluation of in licensing opportunities
- Ensure reliable preclinical, clinical and future commercial supply of safe, high-quality drug products and lead development of manufacturing strategies
- Provide senior technical oversight of process development, manufacturing, analytical development, and control strategies
- Work collaboratively with Quality and Regulatory to ensure robust, phase-appropriate CMC execution
- Oversee clinical supply planning, forecasting, and distribution
- Oversee global CMC regulatory strategy, ensuring alignment with FDA, EMA, and other regulatory authorities
- Oversee preparation, review, and approval of all CMC-related sections of INDs, NDAs, amendments, and variations
- Oversee CMC related regulatory interactions, inspections, and agency meetings
- Ensure ongoing compliance with GMP and evolving regulatory expectations
- Communicate CMC strategy, risks, and decision points clearly to the executive team and Board of Directors
- Synthesize complex technical, regulatory, and operational topics into concise, executive-level summaries and visuals
- Provide leadership with clear options, implications, and recommendations to support strategic and financial decisions
- Act as a trusted advisor on CMC-related matters impacting valuation, timelines, and investor discussions