Senior Director, CMC Lead Product Development
Cytokinetics
August 23, 2026
On-site
San Francisco Bay Area
Operations
Responsibilities:
- Represent CMC (drug substance, drug product, analytical) in governance forums; advocate for CMC; ensure transparent governance, cross-functional ownership, bi-directional communication, and proactive risk mitigation for assigned programs.
- Lead cross-functional CMC product development team meetings and ensure information flow between CMC and program/portfolio governance forums.
- Critically evaluate and integrate raw materials, drug substance, and drug product inputs into development strategies aligned with corporate business objectives.
- Lead/manage one or more CMC project teams; contribute to portfolio-level prioritization; negotiate for resources; influence project timelines to complete required activities.
- Mentor functional representatives; provide feedback to functional managers and identify team growth needs.
- Lead and execute fully integrated product development strategy supporting clinical trials and regulatory approval.
- Support continuous improvement of the CMC Development Roadmap and Governance within the GSC&TO Program Management framework.
- Serve as CMC Lead on high-profile partnerships/collaborations and at the Joint Development Committee.
- Proactively communicate plans and risks to senior leadership through regular updates and periodic reviews.
- Lead/execute in alignment with ICH and applicable contemporary regulatory requirements.
Qualifications:
- Ph.D. in Chemistry, Pharmaceutical Sciences, Engineering, or related field with 10+ years CMC development experience; or M.S. with 15+ years relevant CMC experience managing global teams and CMC activities.
- Experience: small molecule API, formulation development, analytical development, product development (pre-clinical to commercial).
- Strong verbal communication; strong knowledge of technical regulatory requirements/trends (ICH, FDA, EMA, MHRA).
- Demonstrated project/program management, governance, and risk management.
- Preferred: experience leading CMC team through IND and NDA/MAA.
- Skills: negotiating/influencing, collaboration, scientific writing, pharmaceutical/chemical/analytical development knowledge; CMC interdisciplinary experience in oral solid, small molecule space; enterprise thinking and business acumen; experience across asset modalities desirable.
- Represent CMC (drug substance, drug product, analytical) in governance forums; advocate for CMC; ensure transparent governance, cross-functional ownership, bi-directional communication, and proactive risk mitigation for assigned programs.
- Lead cross-functional CMC product development team meetings and ensure information flow between CMC and program/portfolio governance forums.
- Critically evaluate and integrate raw materials, drug substance, and drug product inputs into development strategies aligned with corporate business objectives.
- Lead/manage one or more CMC project teams; contribute to portfolio-level prioritization; negotiate for resources; influence project timelines to complete required activities.
- Mentor functional representatives; provide feedback to functional managers and identify team growth needs.
- Lead and execute fully integrated product development strategy supporting clinical trials and regulatory approval.
- Support continuous improvement of the CMC Development Roadmap and Governance within the GSC&TO Program Management framework.
- Serve as CMC Lead on high-profile partnerships/collaborations and at the Joint Development Committee.
- Proactively communicate plans and risks to senior leadership through regular updates and periodic reviews.
- Lead/execute in alignment with ICH and applicable contemporary regulatory requirements.
Qualifications:
- Ph.D. in Chemistry, Pharmaceutical Sciences, Engineering, or related field with 10+ years CMC development experience; or M.S. with 15+ years relevant CMC experience managing global teams and CMC activities.
- Experience: small molecule API, formulation development, analytical development, product development (pre-clinical to commercial).
- Strong verbal communication; strong knowledge of technical regulatory requirements/trends (ICH, FDA, EMA, MHRA).
- Demonstrated project/program management, governance, and risk management.
- Preferred: experience leading CMC team through IND and NDA/MAA.
- Skills: negotiating/influencing, collaboration, scientific writing, pharmaceutical/chemical/analytical development knowledge; CMC interdisciplinary experience in oral solid, small molecule space; enterprise thinking and business acumen; experience across asset modalities desirable.