Senior Director, CMC Program Management (Phase 3)

Kymera Therapeutics; Massachusetts; On-site; USD 195,000 - 330,000; Full time

Benefits offered by this job

Competitive compensation

Annual bonus eligibility

Equity participation

Comprehensive benefits

Job summary

Kymera Therapeutics is a clinical-stage biotechnology company seeking a Sr. Director of CMC to lead end-to-end CMC program management for mid-to-late-stage programs, shaping timelines for drug substance, product, analytical, and regulatory workstreams in collaboration with CDMOs/CROs.

You will guide Phase 3 planning, technology transfer, and regulatory filings, build integrated plans, drive risk assessments, and mentor cross-functional teams to ensure on-time delivery of high-quality

Qualifications

• PhD, MS in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or related discipline with 10+ years (PhD) or 15+ years (MS) of CMC experience; Sr. Director level requires commensurate additional experience.
• CMC program/project management experience for oral small molecule programs, with experience advancing programs through Phase 3, NDA/MAA submission, process validation, and approval.
• Broad CMC knowledge spanning drug substance, product, and analytical development, with depth to challenge assumptions, assess risk, and support troubleshooting.
• Experience with CDMOs and CROs, technology transfer, GMP manufacturing, and commercial supply management.
• Knowledge of global CMC regulatory requirements (FDA, EMA, ICH), GMP/GLP, and inspection readiness.
• Proven ability to manage complex, cross-functional programs and translate technical concepts into executable plans.
• Exceptional communication, organizational skills and attention to detail.
• Proficiency with project management tools (MS Project, Smartsheet, or equivalent) for integrated timeline and resource planning.

Responsibilities

• Drive end-to-end CMC program management for mid to late-stage programs, including timeline development, critical path identification, risk assessment, and execution tracking.
• Build and maintain integrated plans spanning drug substance, drug product, analytical, quality, regulatory, and supply chain workstreams.
• Support planning and execution of Phase 3, registration and validation campaigns, commercial-scale technology transfer, and commercial readiness activities for oral solid dosage forms.
• Conduct CMC team meetings; ensure clear, timely communication of status, risks, decisions, and issues
• Participate in CDMO/CRO meetings to monitor status, action items, and risks, and ensure alignment with CMC plans. Proactively identify items that require action.
• Coordinate preparation, review, and on-time delivery of CMC components for global regulatory filings, in partnership with Regulatory Affairs and subject matter experts.
• Serve as the CMC timeline and deliverables go-to contact for CMC function leads, core team program managers, and cross-functional partners.
• Develop CMC best practices for decision-making and scenario planning.
• Promote a culture of cross-functional collaboration and execution excellence.

Skills

CMC program management

Phase 3 experience

Regulatory knowledge

Cross-functional leadership

Strong communication

Risk assessment

Analytical thinking

Project management tools

Education

PhD in pharmaceutics or related

MS in related field

Tools

MS Project

Smartsheet

Job description

Kymera Therapeutics is a clinical-stage biotechnology company seeking a Sr. Director of CMC to lead end-to-end CMC program management for mid-to-late-stage programs, shaping timelines for drug substance, product, analytical, and regulatory workstreams in collaboration with CDMOs/CROs.

You will guide Phase 3 planning, technology transfer, and regulatory filings, build integrated plans, drive risk assessments, and mentor cross-functional teams to ensure on-time delivery of high-quality