Senior Director, CMC Lead Product Development

Cytokinetics, Inc.; United States; Hybrid; USD 261,000 - 304,500; Full time

Job summary

Cytokinetics, Inc. is seeking a Senior Director, CMC Lead based in South San Francisco, CA. This hybrid role requires a Ph.D. with at least 10 years of CMC experience to lead cross-functional product development teams and manage CMC activities.

The successful candidate will develop strategies that align with corporate objectives and communicate effectively across various forums. The role also offers a competitive pay range of $261,000 - $304,500 annually and is part of a dynamic team targeting innovative solutions for cardiac muscle dysfunction.

Qualifications

• Requires managing CMC activities with respect to science, technology, and quality.
• Experience leading CMC teams through IND and NDA/MAA is preferred.
• Understanding of pharmaceutical sciences and drug development processes.

Responsibilities

• Represent CMC in governance forums and ensure transparent communication.
• Lead cross-functional CMC product development teams.
• Develop integrated product development strategies.

Skills

Ph.D. in Chemistry or related discipline

10+ years development phase experience

Small molecule API experience

Effective verbal communication

Project and program management

Scientific writing

Knowledge of regulatory requirements

Education

Ph.D. or M.S. in relevant field

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors for cardiac muscle dysfunction. The Senior Director, CMC Lead is a unique opportunity to transform CMC product development into scalable processes that support a growing and complex portfolio.

This position will be based at Cytokinetics’ headquarters in South San Francisco, CA. Hybrid role.

Responsibilities

• Represent CMC (DS, DP, Analytical) in governance forums, serving as spokesperson and advocate for the CMC team, ensuring transparent governance, bi‑directional communication, cross‑functional ownership and proactive risk mitigation for assigned programs.
• Lead cross‑functional CMC product development team meetings and ensure information flow between CMC and all respective program and portfolio governance forums.
• Critically evaluate and integrate raw materials, drug substance and drug product inputs into development strategies, ensuring alignment with overall corporate business objectives.
• Lead and manage one or more CMC project teams, contribute to project prioritization at a portfolio level, negotiate for additional resources when required, and influence project timelines to ensure proper completion of required activities.
• Serve as a mentor for functional representatives, provide feedback and input to their managers, and identify growth needs for team members.
• Develop and execute fully integrated product development strategy in support of clinical trials and regulatory approval.
• Support and contribute to the strategic direction of the GSC&TO Program Management framework for asset development, including continuous improvement of the CMC Development Roadmap and Governance.
• Collaborate across partner organizations, serve as CMC Lead on high‑profile partnerships and collaborations with other pharma/biotech companies and at the Joint Development Committee level, driving joint decisions.
• Proactively communicate plans and risks through regular reviews to senior leadership during the development life cycle and support global filings and approvals.
• Lead and execute in alignment with ICH and applicable regulatory requirements.

Qualifications

• Ph.D. in Chemistry, Pharmaceutical Sciences, Engineering, or related discipline with at least 10 years of development phase experience, or M.S. with 15+ years of relevant CMC experience required to effectively manage global teams and all CMC activities with respect to science, technology, quality, regulatory/compliance requirements, budget and resources.
• Critical experience in small molecule API, formulation development, and/or analytical development and product development from pre‑clinical through to commercial.
• Effective verbal communication at all organizational levels.
• Strong working knowledge of current technical regulatory requirements and trends (ICH, FDA, EMA, MHRA).
• Demonstrated knowledge and experience with project and program management, governance, and risk management.
• Negotiating, influencing, collaboration, and business acumen.
• Multiple product development experiences of leading a CMC team through IND and NDA/MAA preferred.
• Excellent scientific writing and verbal skills.
• Knowledge of pharmaceutical sciences, chemical development, analytical development, and the drug development process.
• CMC interdisciplinary experience and expertise within the oral solid, small molecule space.
• Promotes enterprise thinking and makes well‑informed business decisions while balancing risk.
• Experience across various asset modalities is desirable.

Pay Range: In the U.S., the hiring pay range for fully qualified candidates is $261,000 - $304,500 per year.

Cytokinetics is an Equal Opportunity Employer.