Sr. Director, Clinical Supply Chain

Alkermes
2d$255,000 - $270,000Hybrid

About The Position

An exciting opportunity to lead the strategic and operational management of complex clinical supply activities across all phases of development to provide life-changing therapeutics for patients. The Senior Director of Clinical Supply Chain ensures the uninterrupted, compliant, and cost-effective delivery of investigational products to global clinical trial sites. The ideal candidate will bring deep expertise in supply chain strategy, vendor oversight, and cross-functional collaboration, with a strong understanding of GMP, IRT systems, and regulatory requirements.

Requirements

  • Bachelor’s degree in Life Sciences, Pharmacy, Supply Chain, or related field (advanced degree preferred).
  • 15+ years of experience in clinical supply chain management within the pharmaceutical or biotech industry.
  • Proven leadership in global clinical supply operations, including late-stage and commercial transition.
  • Strong knowledge of GMP, IRT systems, and regulatory requirements.
  • Excellent communication, project management, and vendor negotiation skills.

Responsibilities

  • Develop and execute global clinical supply chain strategies aligned with corporate and clinical development goals.
  • Lead long-range planning and drive the continued development and transformation of supply chain infrastructure to meet the needs of the growing business.
  • Partner with Legal, Finance, Trade Compliance, Quality Assurance, Regulatory Affairs, Clinical Operations, CMC Teams, and other functions across the internal network, to deliver responsibilities aligned with business goals.
  • Oversee demand forecasting, inventory management, and supply planning using simulation tools.
  • Manage packaging, labeling, distribution, and returns of clinical trial materials (CTM) in compliance with GMP and global regulations.
  • Lead IRT system design, implementation, and user acceptance testing for effective drug tracking and randomization.
  • Lead senior level business relationship management with CMOs and third-party logistics providers; develop and ensure adherence to contracts and KPIs.
  • Collaborate with Quality Assurance leadership on vendor qualification and audits.
  • Develop and manage clinical supply budgets, ensuring cost-effective operations.
  • Partner with program project managers to align clinical supply budgets with overall program financial planning and ensure transparency in forecasting, tracking, and reporting.
  • Ensure inspection readiness for global regulatory audits.
  • Maintain documentation and SOPs to support compliance and continuous improvement.
  • Mentor and continue to build a high-performing clinical supply chain team.
  • Foster a culture of accountability, innovation, and cross-functional collaboration.
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