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.