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CMC Strategy & Leadership:
- 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.
- Build scalable CMC roadmaps aligned with clinical milestones, financing events, and long-term corporate strategy.
Development, Manufacturing & Supply:
- Ensure reliable preclinical, clinical and future commercial supply of safe, high-quality drug products and lead development of manufacturing strategies to ensure capacity for the product portfolio.
- 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 that supports Phase 1 through Phase 3 and commercial readiness
Regulatory & Compliance:
- 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
Faeth Therapeutics
Faeth Therapeutics is a clinical-stage oncology company listed on Nasdaq that recently raised $200M in funding. They are a small, focused team where every person has direct impact — united by a shared commitment to care deeply, create boldly, and never stop learning.