Senior Director, Clinical Supply Chain

Company: Cytokinetics
Location: San Francisco
Posted on: April 1, 2025

Job Description:

Senior Director, Clinical Supply ChainSenior Director, Clinical Supply ChainApply locations South San Francisco, California time type Full time posted on Posted 24 Days Ago job requisition id R64Cytokinetics 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 Description:Job PurposeThe 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 ResponsibilitiesLeadership 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.QualificationsEducation:
• 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.$276,000 - $306,000Our 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 OffersRecently, 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 talentacquisition@cytokinetics.com.Please visit our website at: www.cytokinetics.comCytokinetics is an Equal Opportunity Employer
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Keywords: Cytokinetics, San Francisco , Senior Director, Clinical Supply Chain, Professions , San Francisco, California