Senior Director Clinical Supply Chain

Cytokinetics is a latestage specialty cardiovascular biopharmaceutical company focused on discovering developing and commercializing firstinclass muscle activators and nextinclass 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.

The Senior Director Clinical Supply Chain will lead the strategic development and of the global clinical supply chain to support Cytokineticss clinical development programs. This role ensures the timely compliant delivery of highquality clinical trial materials and investigational medicinal products through crossfunctional collaboration efficient resource management and vendor oversight. The incumbent will also drive innovation and continuous improvement within clinical supply chain processes while ensuring alignment of Product Strategy Teams (PSTs) and Study Operation Teams (SOTs) as well as maintaining regulatory compliance in order to meet corporate objectives.

Key Responsibilities

Leadership and Strategy:

• Direct and oversee the endtoend clinical supply chain from demand planning to distribution ensuring ontime compliant delivery aligned with clinical development plans.

• Collaborate with Product Strategy Teams (PSTs) and Study Operation Teams (SOTs) to proactively manage supply and demand planning and mitigate risks to the continued advancement of the clinical programs.

• Provide strategic leadership to internal and external teams ensuring all clinical supply chain activities support broader organizational goals.

Operational Excellence:

• Led the S&OP process through development and management of clinical supply plans including demand forecasting inventory management and expiry extension strategies to minimize waste.

• Lead clinical supply operations including label generation and approval packaging and labeling release distribution and cold chain management.

• Oversee IRT/IWRS system implementation testing and maintenance.

Vendor and Resource Management:

• In collaboration with Sourcing and Technical Operations manage the selection onboarding and performance of Contract Manufacturing Organizations (CMOs) and suppliers in support of Clinical Supply activities.

• Conduct supply chain contractor audits in partnership with Quality Assurance and ensure compliance with cGMP and GDP standards.

Regulatory Compliance:

• Ensure all clinical supply chain activities adhere to global regulatory requirements including those from FDA EMA and major health authorities in regions such as Japan (PMDA) China (NMPA) and Brazil (ANVISA).

• Review and contribute to regulatory documentation including IND IMPD and NDA submissions as well as technical documents like clinical label text and master batch records.

Continuous Improvement:

• Serve as a subject matter expert in clinical supply chain processes driving innovation and implementing best practices to enhance operational efficiency.

• Author and Implement updated processes SOPs and policies to maintain GMP integrity and harmonized quality clinical supply chain practices

• Develop and monitor key performance indicators (KPIs) to assess and improve supplier and operational performance.

People and Budget Management:

• Build and lead a highperforming clinical supply chain team fostering a culture of accountability collaboration and innovation.

• Establish and manage budgets ensuring alignment with organizational financial goals.

Qualifications

Education:

• Bachelors or Masters degree in Chemistry Pharmaceutics Supply Chain Management or a related field. An advanced degree is preferred.

Experience:

• 15 years of progressive experience in clinical supply chain and logistics with at least 5 years managing global teams.

• Extensive experience in global clinical trials particularly for Phase 3 Cardiovascular studies.

• Demonstrated expertise in clinical supply chain processes including packaging labeling and cold chain logistics.

• Proven experience working with CMOs and understanding global import/export regulations.

Skills:

• Strong leadership and team development skills with a track record of building and managing highperforming teams.

• Exceptional problemsolving decisionmaking and project management abilities.

• Excellent written and verbal communication skills with the ability to effectively present complex information to diverse audiences.

• Advanced proficiency in change management and crossfunctional collaboration.

Preferred:

• Experience with oral solid dose and associated manufacturing/packaging and regulatory documentation.

• Familiarity with IRT/IWRS systems capabilities and their operational requirements.

Travel:

• Up to 25 domestic and international travel may be required.

Pay Range:

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 ourGeneral Data Protection Regulation (GDPR) policyPRIOR 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.

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Cytokinetics is an Equal Opportunity Employer