Job Purpose

The Senior Director, Clinical Supply Chain, will lead the strategic development and execution of the global clinical supply chain to support Cytokinetics’s clinical development programs. This role ensures the timely, compliant delivery of high-quality clinical trial materials and investigational medicinal products through cross-functional 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 end-to-end clinical supply chain, from demand planning to distribution, ensuring on-time, 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 high-performing clinical supply chain team, fostering a culture of accountability, collaboration, and innovation.
• Establish and manage budgets, ensuring alignment with organizational financial goals.

 

Qualifications

Education:

• Bachelor's or Master's 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 high-performing teams.
• Exceptional problem-solving, decision-making, 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 cross-functional 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.