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Vice President, Chemistry, Manufacturing, and Controls (CMC) page is loaded

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

Apply locations South San Francisco, California time type Full time posted on Posted 3 Days Ago job requisition id R290

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 expertise in small molecule drug development.

• Proven experience leading CMC efforts from preclinical development through NDA/MAA submission and commercial launch.

• Demonstrated success managing fully outsourced manufacturing and testing operations (CDMOs and CTLs).

• Direct experience with U.S. regulatory agencies (FDA) in addition to European regulators (EMA).

• Strong knowledge of cGMP, ICH guidelines, and global regulatory expectations.

• Ability to work on-site in South San Francisco a minimum of 4-5 d ays per week.

Key Competencies:

• Strong technical foundation with the ability to apply scientific and engineering principles to problem-solving.

• Exceptional cross-functional communication and leadership skills.

• Strategic mindset with operational agility—capable of balancing big-picture vision with tactical execution.

• Skilled at influencing, negotiating, and aligning stakeholders at all levels.

• Demonstrated leadership in building teams, managing change, and fostering a high-performance, inclusive culture.

• High ethical standards, sound judgment, and unwavering commitment to quality and compliance.

Critical Competencies for Success

Setting Strategy:

• Creates and articulates an inspiring, forward-looking CMC vision that aligns with the company's growth strategy.

• Uses data-driven decision-making to align functional goals with corporate objectives .

• Champions innovation while assessing organizational capacity for change and execution.

Executing for Results:

• Sets ambitious but achievable goals and holds teams accountable for delivering results.

• Navigates ambiguity with resilience and adapts quickly to changing priorities.

• Makes informed decisions while balancing risks and strategic opportunity .

Leading Teams:

• Attracts, develops, and retains top talent; builds cohesive, high-performing teams.

• Leads by example with humility, accountability, and a continuous improvement mindset.

• Inspires teams with integrity, clarity of purpose, and a relentless focus on excellence.

This is a unique opportunity for a seasoned CMC leader to take ownership of a mission-critical function and help guide a high-growth organization to successful commercialization.

Pay Range:

In the U.S., the hiring pay range for fully qualified candidates is $317,300-$350,700 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications

• We will never request personal information such as banking details until after an official offer has been accepted and verified

• We will never request that you purchase equipment or other items when interviewing or hiring

• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at ...@cytokinetics.com

Please visit our website at:www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

About Us

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.

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