Director or Senior Director, CMC Program Management
Kymera Therapeutics
Kymera Therapeutics seeks a Director or Senior Director to manage chemistry, manufacturing, and controls programs for mid-to-late-stage oral small molecule degrader candidates. The role encompasses timeline planning, cross-functional coordination, regulatory submission support, and CMC strategy for programs advancing through clinical and commercial stages.
Responsibilities
- Drive end-to-end CMC program management including timeline development, critical path identification, and risk assessment
- Build and maintain integrated plans spanning drug substance, drug product, analytical, quality, regulatory, and supply chain
- Support Phase 3, registration, validation, and commercial readiness activities for oral solid dosage forms
- Lead CMC team meetings and communicate status, risks, and decisions to stakeholders and external partners
- Coordinate CMC documentation preparation and timely delivery for global regulatory filings
Requirements
- Advanced degree in pharmaceutics, pharmaceutical sciences, chemistry, or chemical engineering preferred
- 10+ years of CMC program management experience for oral small molecule drugs
- Experience advancing programs through Phase 3, NDA/MAA submission, and process validation
- Broad technical knowledge of drug substance, drug product, and analytical development
- Prior experience with CDMOs, CROs, technology transfer, and GMP manufacturing
- Demonstrated ability to manage timelines, assess risk, and coordinate across functions
$195k - $330k
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