Isomorphiclabs

Associate Director, Clinical Supply Chain, Cambridge, MA

Cambridge, MA. Posted a month ago

The role

This person will lead end-to-end clinical trial material planning, vendor management, packaging, labeling, inventory management, and global distribution operations. They will serve as the clinical supply authority within a Pharmaceutical Sciences & CMC Manufacturing team.

What you will do

  • Build and maintain flexible clinical supply models for demand forecasting
  • Manage investigational product fulfillment and site replenishment strategies
  • Author and review Investigational Product Handling and Pharmacy Manuals
  • Direct secondary packaging, blinding/kitting strategies, and label generation
  • Select and manage central and regional clinical depots
  • Oversee domestic shipping lines, chain-of-custody protocols, and specialty courier operations
  • Implement continuous temperature monitoring solutions and triage excursions
  • Direct end-of-study IP reconciliation, returns, and authorized destruction
  • Partner with IRT providers to design system functional specifications and supply strategies
  • Direct technical RFPs, contract negotiations, and vendor performance metrics

Required qualifications

  • Bachelor’s or Master’s degree in Supply Chain Management, Logistics, Life Sciences, Chemical/Industrial Engineering, Pharmacy, or a related discipline
  • 7+ years of direct experience in clinical supply chain management, clinical logistics, or investigational material management within a pharmaceutical or biotechnology company
  • Proven experience supporting clinical trials, including logistics, rapid-response replenishment, and flexible kit demand
  • Practical experience managing secondary packaging, clinical labeling, depot operations, and temperature-controlled transportation
  • Thorough working knowledge of cGMP, cGCP, Good Distribution Practices (GDP)
  • Experience working with Regulatory and Legal functions regarding global clinical supply regulations
  • Exceptional communication, negotiation, and cross-functional leadership skills

Nice to have

  • Prior experience in a high-growth, venture-backed startup or lean biotech environment
  • Direct experience managing clinical supply logistics for biologic modalities and ancillary parenteral administration supplies
  • Experience managing supplies for randomized, double-blind, placebo/comparator-controlled clinical trials
  • Familiarity with Section 3.2.P (Drug Product / Container Closure) labeling sections or pharmacy-related components of regulatory filings (IND/IMPD)

About the company

Isomorphic Labs (IsoLabs) was launched in 2021 to advance human health by building on and beyond the Nobel-winning AlphaFold system. The company uses AI models to accelerate scientific discovery and design novel molecules.

Associate Director, Clinical Supply Chain, Cambridge, MA at Isomorphiclabs | JobZoey