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Isomorphic Labs, an AI-driven drug discovery company founded in 2021, is seeking an Associate Director of Clinical Supply Chain to lead end-to-end clinical trial material (CTM) operations. Reporting to the Head of Early Development, you will serve as the clinical supply authority within a lean Pharmaceutical Sciences & CMC Manufacturing team, partnering directly with Clinical Operations and the broader Clinical Development organization.
You will architect and scale clinical supply operations as the company's pipeline advances, managing dynamic demand forecasting, rapid-response resupply strategies, packaging and labeling design, depot and logistics operations, temperature monitoring and excursion management, and end-of-study reconciliation and destruction workflows. You will direct vendor relationships with clinical packaging/labeling CMOs, logistics providers, and storage depots; oversee batch release and import/export documentation; and ensure strict compliance with cGMP, ICH, GDP, and CGP standards.
Key responsibilities include: building flexible clinical supply models to support unpredictable trial timelines while minimizing drug waste; managing investigational product fulfillment and site replenishment across trial sites; authoring and reviewing Investigational Product Handling and Pharmacy Manuals; directing secondary packaging, blinding/kitting strategies, and label generation; selecting and managing central and regional clinical depots; implementing continuous temperature monitoring and triaging excursions in real time; coordinating with Analytical Development on retest/expiry dating; managing qualified domestic and international shipping vendors and QP release coordination; serving as the primary clinical supply liaison to Clinical CROs; partnering with Clinical Operations and IRT/RTSM providers on system design and User Acceptance Testing; tracking regulatory approvals and import/export requirements for site activation; structuring transitions from early open-label studies to larger randomized, double-blind, placebo/comparator-controlled trials; driving selection and implementation of supply chain enterprise software and digital dashboards; and directing technical RFPs, contract negotiations, SOWs, and KPI/SLA tracking for vendors.
This is a high-growth role designed to scale with the company's clinical development activities across multiple therapeutic areas and drug modalities.
REQUIREMENTS:
Essential:
- 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 a pharmaceutical or biotechnology company
- Proven experience supporting clinical trials with firm grasp of logistics, rapid-response replenishment, and flexible kit demand
- Practical experience managing secondary packaging, clinical labeling, depot operations, and temperature-controlled transportation planning/execution
- Thorough working knowledge of cGMP, cGCP, Good Distribution Practices (GDP), and global clinical supply regulations; experience working with Regulatory and Legal functions
- Exceptional communication, negotiation, and cross-functional leadership skills with proven ability to coordinate complex operational timelines across diverse technical and clinical stakeholders
Preferred:
- Prior experience in high-growth, venture-backed startup or lean biotech environment requiring autonomy, technical versatility, and building processes from the ground up
- 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, including blinding maintenance and placebo matching
- Familiarity with Section 3.2.P (Drug Product / Container Closure) labeling sections or pharmacy-related components of regulatory filings (IND/IMPD)
