Associate Director, Clinical Supply Chain, Cambridge, MA

Your impact 

We are seeking a proactive, self-driven, highly organized, and entrepreneurial Clinical Supply Chain colleague to lead end-to-end clinical trial material (CTM) planning, vendor management, packaging, labeling, inventory management, and global distribution operations. Reporting directly to the Head of Early Development, you will serve as the clinical supply authority within a lean Pharmaceutical Sciences & CMC Manufacturing team, acting as a direct partner to Clinical Operations and the larger Clinical Development organization. As part of an AI-first company, you will help us reimagine how we bring new medicines to patients.

This role is designed for growth. As our pipeline advances, you will be the foundational architect of our clinical supply operations - scaling systems, processes, and vendor networks to support future clinical studies in different modalities and therapeutics areas.

Operating within an agile model, you will execute operations through external clinical packaging and labeling vendors, central/regional depots, specialized temperature-controlled chain couriers, and Interactive Response Technology (IRT/RTSM) providers. Internally, you will bridge between drug manufacturing with Clinical Operations for clinical trial execution.

What you will do 

Clinical Supply Planning & Execution 

• 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 clear site-level guidance for drug storage, handling, accountability, and dose preparation, reconciliation, and destruction.

Packaging, Labeling & Distribution Logistics 

• 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.
• Understand the latest retest/expiry dating for clinical supplies by coordinating with Analytical Development to get the latest shelf life on clinical supplies to ensure recovery/recalls can be done without interrupting or delaying the clinical study.
• Temperature Monitoring & Excursions (TEs): Implement continuous temperature monitoring solutions across shipments and depot storage.
• Triage temperature excursions in real time, partnering with Analytical Chemistry and Quality Assurance to assess stability impact and execute rapid product disposition.
• Accountability, Reconciliation & Destruction: Direct end-of-study IP reconciliation, returns, and authorized destruction workflows across trial sites and depots in compliance with cGMP/GCP and ICH standards.
• Direct qualified domestic and international shipping vendors and distribution strategies , QP release coordination , import/export permits/license requirements, depot networks and VAT planning and recovery.

Clinical CRO, IRT/RTSM & Clinical Operations Partnership 

• Clinical CRO Alignment: Serve as the primary clinical supply chain liaison to Clinical CROs, synchronizing supply readiness with clinical timelines.
• IRT/RTSM System Implementation: Partner with Clinical Operations and IRT providers to design system functional specifications, supply buffer strategies, reorder triggers, predictive resupply logic, and User Acceptance Testing (UAT).
• Site Activation Readiness: Track country- and site-level regulatory approvals, import/export requirements, and depot release gates to ensure Investigational Product arrives on-site well in advance of First Patient In (FPI).

Supply Chain Scalability 

• Small Molecule Scaling: Structure the transition from early, open-label studies to larger, multi-center, randomized, double-blind, placebo/comparator-controlled trials, including managing matching placebo/comparator supplies and complex blinded packaging.
• Supply Systems Evolution: Drive the selection and implementation of supply chain enterprise software, inventory tracking systems, and digital dashboards as company development activities scale.

Quality, Compliance & Vendor Governance

• Vendor Management: Direct technical RFPs, contract negotiations, Statements of Work (SOWs), and performance metrics (KPIs/SLAs) for clinical packaging/labeling CMOs/CPOs (Contract Manufacturing/Packaging Organizations), logistics providers, and storage depots.
• Batch Release & Import/Export Documentation: Review and approve packaging/labeling batch records, release documentation, material shipping authorizations, and domestic transport permits in partnership with QA.
• GxP Compliance & Audit Readiness: Ensure all clinical supply activities comply strictly with cGMPs, ICH, GDPs and CGPs and internal quality management systems.
• Direct technical RFIs, RFPs, SOWs, and KPIs, while tracking trial supply spend and vendor invoice approvals.

Skills and qualifications 

Essential:

• Education: Bachelor’s or Master’s degree in Supply Chain Management, Logistics, Life Sciences, Chemical/Industrial Engineering, Pharmacy, or a related discipline.
• Industry Experience: 7+ years of direct experience in clinical supply chain management, clinical logistics, or investigational material management within a pharmaceutical or biotechnology company.
• Study Start-up Experience: Proven experience supporting clinical trials, with a firm grasp of logistics, rapid-response replenishment, and flexible kit demand.
• Packaging & Distribution: Practical experience managing secondary packaging, clinical labeling,depot operations, and temperature-controlled transportation planning/execution.
• GxP & Regulatory Rigor: Thorough working knowledge of cGMP, cGCP, Good Distribution Practices (GDP); global clinical supply regulations and experience working with Regulatory and Legal functions in these areas.
• Exceptional communication, negotiation, and cross-functional leadership skills, with a proven ability to coordinate complex operational timelines across diverse technical and clinical stakeholders.

Preferred: 

• Prior experience in a high-growth, venture-backed startup or lean biotech environment where autonomy, technical versatility, and building processes from the ground up are required.
• Biologics Supply Chain Experience: Direct experience managing clinical supply logistics for biologic modalities and ancillary parenteral administration supplies.
• Blinded Trial Experience: 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).