Senior Director, Clinical Supply Chain
Locations: South San Francisco, California
Time Type: Full Time
Posted On: Posted 2 Days Ago
Job Requisition ID: R64
About Cytokinetics:
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.
Job Purpose:
The Senior Director, Clinical Supply Chain will lead the strategic development and execution of the global clinical supply chain to support Cytokinetics’ 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 with Product Strategy Teams (PSTs) and Study Operation Teams (SOTs), as well as maintaining regulatory compliance to meet corporate objectives.
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.
Provide strategic leadership to internal and external teams, ensuring clinical supply chain activities support broader organizational goals.
Operational Excellence:
Lead the S&OP process through the development and management of clinical supply plans, including demand forecasting, inventory management, and expiry extension strategies.
Oversee clinical supply operations, including label generation and approval, packaging and labeling, release, distribution, and cold chain management.
Manage IRT/IWRS system implementation, testing, and maintenance.
Vendor and Resource Management:
Manage the selection, onboarding, and performance of Contract Manufacturing Organizations (CMOs) and suppliers in collaboration with Sourcing and Technical Operations.
Conduct supply chain contractor audits with Quality Assurance to ensure compliance with cGMP and GDP standards.
Regulatory Compliance:
Ensure all clinical supply chain activities adhere to global regulatory requirements, including FDA, EMA, PMDA (Japan), NMPA (China), and ANVISA (Brazil).
Review and contribute to regulatory documents including IND, IMPD, NDA submissions, 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 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 in alignment with organizational financial goals.
Qualifications:
Education:
Bachelor's or Master's degree in Chemistry, Pharmaceutics, Supply Chain Management, or a related field. Advanced degree 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.
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.
Advanced proficiency in change management and cross-functional collaboration.
Preferred:
Experience with oral solid dose manufacturing/packaging and regulatory documentation.
Familiarity with IRT/IWRS systems and their operational requirements.
Travel:
Up to 25% domestic and international travel may be required.
Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $276,000 - $306,000 USD per year.
Base pay will consider internal equity, geographic region, job-related knowledge, skills, and experience among other factors.
Commitment to Diversity and Inclusion:
Cytokinetics celebrates diverse backgrounds and encourages all candidates to apply even if they do not meet every qualification. Passion, innovation, and commitment to patients are at the heart of Cytokinetics' mission.
Fraud Warning:
All legitimate offers from Cytokinetics will come directly from our official email domain (cytokinetics.com) after a formal interview process. We do not conduct interviews via non-standard text messaging applications, request banking information prior to an accepted offer, or ask candidates to purchase equipment during the hiring process. Please contact talentacquisition@cytokinetics.com if you have any concerns.
Website: www.cytokinetics.com
Equal Opportunity Employer
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