← All roles

Associate Director, Clinical Supply Chain, Cambridge, MA

Isomorphic Labs· Clinical
Apply on company site
Cambridge, MAfull-timePosted 3w ago

About the role

Proactive, self-driven Clinical Supply Chain leader responsible for end-to-end clinical trial material planning, vendor management, packaging, labeling, inventory, and global distribution. Partners with Clinical Operations and the broader Clinical Development organization in an AI-forward, growth-oriented biotech environment.

Responsibilities

  • Dynamic Demand Forecasting: Build and maintain flexible clinical supply models tailored to the unpredictable pace of clinical trials, ensuring uninterrupted patient dosing while minimizing drug waste.
  • Rapid-Response Resupply: Manage flexible investigational product fulfillment and site replenishment strategies to support dynamic protocol milestones, dose adjustments, and study demand fluctuations across participating trial sites.
  • Pharmacy Manuals & Site Support: Collaborate with internal colleagues and Clinical CROs to author and review the Investigational Product (IP) Handling and Pharmacy Manuals, establishing site-level guidance for drug storage, handling, accountability, and dose preparation, reconciliation, and destruction.
  • Packaging & Label Design: Direct secondary packaging, blinding/kitting strategies, and label generation for clinical trial supplies, ensuring regulatory compliance with applicable regional and global standards and regulations.
  • Depot & Logistics Management: Select and manage central and regional clinical depots; oversee qualified domestic shipping lines, secure chain-of-custody protocols, and specialty courier operations.
  • Temperature Monitoring & Excursions: Implement continuous temperature monitoring solutions across shipments and depot storage; triage excursions in real time and collaborate to assess stability impact and disposition.
  • Accountability, Reconciliation & Destruction: Direct end-of-study IP reconciliation, returns, and authorized destruction workflows across trial sites and depots per cGMP/GCP and ICH standards.
  • Vendor Governance: Lead RFIs/RFPs/SOWs, negotiate contracts, and establish KPIs/SLAs with CMOs/CPOs, logistics providers, and depots; manage trial supply spend and vendor invoices.
  • Batch Release & Documentation: Review and approve packaging/labeling batch records, release documentation, shipping authorizations, and permits with QA.
  • GxP Compliance: Ensure clinical supply activities comply with cGMP, ICH, GDPs, CGPs and internal quality systems.
  • I&T Partnerships: Coordinate with Clinical CROs, IRT/RTSM providers, and Clinical Operations to align supply readiness with timelines and enable UAT and system specs.
  • Regulatory & Import/Export: Manage import/export permits, regulatory requirements, depot release gates, and maintenance of regulatory filings related to drug product labeling components.

Qualifications

  • Bachelor’s or Master’s degree in Supply Chain Management, Logistics, Life Sciences, Chemical/Industrial Engineering, Pharmacy, or related discipline.
  • 7+ years of direct experience in clinical supply chain management, clinical logistics, or investigational material management within pharma/biotech.
  • Experience supporting clinical trials with logistics, rapid-response replenishment, and flexible kit demand.
  • Practical experience in secondary packaging, clinical labeling, depot operations, and temperature-controlled transportation planning/execution.
  • Thorough knowledge of cGMP, cGCP, GDP; familiarity with global clinical supply regulations and collaboration with Regulatory/Legal teams.
  • Excellent communication, negotiation, and cross-functional leadership; ability to coordinate complex operational timelines across diverse stakeholders.

Skills

Required:Clinical supply planningPackaging and labelingVendor governance

Benefits

  • Hybrid working model with in-person collaboration
  • Engagement in cutting-edge AI-enabled drug discovery environment
  • Culture fostering curiosity, bravery, determination, and collaboration
Last updated Sep 30, 2026. Interested? Apply on the company site.

About Isomorphic Labs

Reimagining Drug Discovery Process with AI

Isomorphic Labs is building a future where frontier AI can help to unlock deeper scientific insights, faster breakthroughs, and life-changing medicines.

AIBiotechnologyDrug DiscoveryPharmaceuticalsliquid-ai-recruiting-target
Company profileWebsite

More open roles at Isomorphic Labs