Vice President, Chemistry, Manufacturing, and Controls (CMC)

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.

Reporting to the SVP of Global Supply Chain &Technical Operations, the Vice President (VP) of Chemistry, Manufacturing, and Controls (CMC) will lead the transition from a clinical-stage organization to one prepared for commercial-stage operations. This executive will be responsible for navigating technical and regulatory challenges while shaping a best-in-class CMC function. 

The ideal candidate brings deep technical, operational, regulatory, strategic, and quality expertise, along with a proven track record of leading CMC functions in innovative biotech or pharmaceutical organizations. This role includes oversight of drug substance and drug product development, analytical development, clinical manufacturing, and supply chain operations. 

The VP of CMC will provide strategic direction, technical guidance, and long-range planning for all CMC activities from IND-enabling studies through to NDA submission and commercial launch. They will build and foster relationships with CDMOs and CTLs, ensuring regulatory compliance, operational excellence, and high-performance standards across CMC deliverables. 

A collaborative and motivational leader, the successful candidate thrives in a dynamic, entrepreneurial biotech environment. They will be adept at managing broad responsibilities, engaging cross-functional stakeholders, and delivering results within a matrixed, fast-paced culture. This is a highly visible and impactful role with regular exposure to the C-suite. 

Key Responsibilities: 

• Develop and execute an adaptable and sustainable CMC strategy to support development and commercialization of the company’s pipeline assets. 

• Lead all CMC functions—drug substance, drug product, and analytical sciences—across internal and external teams from IND enabling through NDA and post-approval lifecycle management. 

• Oversee outsourced activities at CDMOs and CTLs, ensuring quality, compliance, and timely execution. 

• Build and lead a high-performing CMC organization; hire, mentor, and develop team members aligned with company goals and scientific rigor. 

• Define and implement systems and processes to align the CMC function with internal stakeholders (Regulatory, Quality, Clinical, Legal/IP, External Manufacturing & Supply, and Finance) and external partners. 

• Lead CMC team in the authoring and review of CMC sections for regulatory submissions (INDs, NDAs, MAAs) and participate in regulatory authority interactions and inspections. 

• Proactively manage CMC-related risks and implement mitigation strategies to ensure project continuity and success. 

• Develop and manage department budgets and ensure fiscal responsibility for CMC operations and external engagements. 

Candidate Profile and Required Experience 

Minimum Qualifications: 

• Advanced degree (MS/PhD) in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field. 

• 20+ years of progressive leadership in CMC and Technical Operations, with deep