Kymera Therapeutics

Director or Senior Director, CMC Program Management

Kymera Therapeutics$195K — $330K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • PhD, M.S., or equivalent in relevant field with 10+ years (Ph.D.) or 15+ years (M.S.) of CMC experience.
  • CMC project management experience for oral small molecule programs, particularly in Phase 3 and NDA/MAA submission.
  • Broad technical knowledge in drug substance, product, and analytical development, with the ability to challenge assumptions and assess risks.
  • Experience collaborating with CDMOs and CROs in technology transfer and GMP manufacturing.
  • Familiarity with global CMC regulatory standards (FDA, EMA) and compliance readiness.
  • Proven track record in managing complex, cross-functional programs and translating technical data into actionable plans.
  • Excellent communication, organization, and detail-oriented skills.

Responsibilities

  • Drive CMC program management through all phases, focusing on timelines and risk assessment.
  • Build integrated plans for drug substance, product, quality, and regulatory workstreams.
  • Support execution of Phase 3 campaigns and commercial technology transfers for dosage forms.
  • Lead CMC team meetings and communicate project status, risks, and decisions effectively.
  • Monitor CDMO/CRO progress and ensure alignment with CMC plans, addressing action items.
  • Coordinate the preparation and timely submission of CMC components for global regulatory filings.
  • Act as the main point of contact for CMC timelines and deliverables across teams.
  • Develop best practices for decision-making and cross-functional collaboration.

Benefits

  • Comprehensive healthcare coverage, including medical, dental, and vision.
  • Generous vacation policy and paid time off.
  • 401(k) plan with company match and investment options.
  • Opportunities for professional development and training support.
  • Flexible working arrangements to promote work-life balance.
Full Job Description


How you'll make an impact:
  • 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 and experience you'll bring:
  • PhD., M.S., or equivalent in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or a related discipline, with 10+ years (Ph.D.) or 15+ years (M.S.) of CMC experience; Sr. Director level requires commensurate additional experience and demonstrated scope.
  • 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 technical knowledge spanning drug substance, drug product, and analytical development, with sufficient depth to challenge assumptions, assess risk, and support troubleshooting.
  • Prior experience in working with CDMOs and CROs, technology transfer, GMP manufacturing, and commercial supply management.
  • Working knowledge/experience in global CMC regulatory requirements and expectations (FDA, EMA, ICH), GMP/GLP compliance, 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 (e.g., MS Project, Smartsheet, or equivalent) for integrated timeline and resource planning.


Compensation
  • Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
  • The anticipated base salary range for this role is $195,000 - $330,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
  • Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate's depth of experience and the capabilities they bring to the position.

About Kymera Therapeutics

Kymera Therapeutics is a clinical-stage biopharmaceutical company that is focused on discovering and developing novel small molecule therapeutics that selectively degrade disease-causing proteins by harnessing the body's own natural protein degradation system. The company's proprietary targeted protein degradation platform, Pegasus, is designed to harness the body's natural protein recycling machinery to degrade disease-causing proteins, with a focus on undruggable and difficult-to-drug targets. Kymera's initial programs are focused on oncology and immunology, with a goal of delivering transformative therapies for patients with previously untreatable diseases. Kymera was founded in 2015 and is headquartered in Cambridge, MA.
Learn more about Kymera Therapeutics
Size
75 employees
Market Cap
$1.4 billion
Industry
Founded
2017
NASDAQ

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