Associate Director, Clinical Supply Chain Lead

Responsibilities:

• Manage end-to-end clinical supply chain readiness and execution for time-critical, patient-specific cell therapy logistics (from manufacturing slot alignment through product release, shipment, site receipt, and Day-of-Dose).
• Design and continuously refine clinical supply chain readiness plans (critical path activities, dependencies, risks, decision points).
• Author and maintain logistics SOPs, chain-of-custody processes, and the Drug Product Handling & Preparation Manual; own site training content for Day-of-Dose.
• Select, onboard, qualify, and manage external logistics partners, specialty couriers, and service providers.
• Align clinical demand, manufacturing slots, batch release timing, and logistics execution; proactively elevate scheduling conflicts.
• Own day-to-day patient-specific scheduling and shipment coordination, coordinating transport constraints with QA release windows.
• Monitor live shipments and lead exception handling (delays/deviations/temperature excursions), including process FMEA development.
• Support clinical site activation by assessing site constraints (storage capabilities, OR workflows, delivery hours).
• Establish technical escalation pathways (intake, triage, decision ownership) and communicate timelines/risks.
• Support deviation investigations and CAPAs; incorporate learnings into standard workflows.
• Engage and influence multidisciplinary teams; prioritize multiple projects and meet deadlines.

• Bachelor’s in Supply Chain, Logistics, Life Sciences, or related field (or equivalent experience).
• 6–10+ years in supply chain, technical operations, CMC, or related biotech/pharma roles.
• Hands-on clinical trial supply experience, including cell therapy or gene therapy.
• Strong GMP/GCP/GDP and chain-of-custody knowledge.
• Proven critical path management, dependency tracking, and cross-functional coordination (Excel, Smartsheet, or MS Project).
• Experience authoring SOPs/work instructions in regulated environments.
• Ability to translate complex technical/scientific concepts into clear operational plans.

• Experience supporting first-in-human/early-phase clinical cell therapy programs.
• Expertise in time- and temperature-sensitive logistics.
• Exposure to qualification/validation/dry-run readiness testing for clinical site delivery.

• Base pay range: $170,000–$210,000/year (varies by factors).
• Cambridge, MA; hybrid work.
• May require flexible hours for time-critical logistics windows.