We're looking for a Manager of Clinical Supply Chain to own investigational product supply for our clinical trials, end to end. You'll be the connective tissue between demand forecasting, packaging and labeling, depot distribution, IRT, QA, and our vendor network, making sure the right product reaches the right site at the right time, while keeping waste, stock-outs, and protocol risk to a minimum.
This is a highly cross-functional role for someone who thinks in systems, is comfortable owning ambiguity, and wants direct ownership over how clinical supply strategy comes together across a global trial portfolio.
What You'll Do
Clinical Supply Planning
- Translate protocols, enrollment forecasts, and visit schedules into comprehensive, country- and site-specific supply plans, including overage, buffer, and resupply strategies, launch sequencing, and depot stocking approaches.
- Build supply risk assessments and mitigation strategies covering product expiry, enrollment variability, and dosing requirements.
Demand Forecasting & Inventory Management
- Build and maintain demand forecasts aligned with IRT assumptions and enrollment scenarios.
- Monitor inventory across CMOs, packaging vendors, depots, and clinical sites; manage expiry and resupply.
- Own reconciliation, accountability, returns, and destruction planning for clinical supplies.
IRT & Supply Integration
- Partner with the IRT Manager to define shipment triggers, kit type strategies, assignment logic, resupply thresholds, and depot-to-site logic.
- Ensure packaging configurations and labeling groups are accurately reflected in the IRT system.
Packaging & Labeling Oversight
- Define packaging run strategies based on demand forecasts and enrollment curves.
- Approve kit designs, label text groups, and country-specific requirements.
- Coordinate packaging schedules with CMOs and packaging vendors.
Depot & Distribution Management
- Oversee depots and couriers, partnering with QA on qualification processes.
- Establish shipping lanes, temperature profiles, chain of custody, inventory governance, and resupply cadence.
- Troubleshoot shipment delays, temperature excursions, and customs holds.
- Oversee vendor distribution specifications to ensure compliance with study requirements.
- Manage relationships and performance of packaging, depot, and sourcing vendors.
- Review SOWs, change orders, and performance metrics; lead escalations and continuous improvement initiatives.
Operational Excellence
- Monitor live study performance, support urgent resupply decisions, and drive risk mitigation actions.
- Serve as the Clinical Supply Subject Matter Expert (SME) on study team meetings.
Process Improvement & Governance
- Develop and refine SOPs for clinical supply management.
- Lead lessons-learned reviews at study start-up and during study conduct.
- Implement and track KPIs, including stock-outs, waste, forecast accuracy, and shipment performance.
- Maintain records supporting end-to-end accountability across the study lifecycle.
Compliance
- Ensure all supply activities are GxP-compliant and inspection-ready.
- Maintain documentation suitable for FDA, EMA, or QP review.
- Manage TMF requirements, including study- and country-specific needs and QP release coordination as applicable.
What You Bring
- Bachelor's degree required; advanced degree preferred.
- 6+ years of experience in the pharmaceutical industry.
- Experience with biologics and cold chain products.
- Proven track record forecasting clinical trial material needs for international trials.
- Ability to thrive in a fast-paced environment with minimal supervision, adapting quickly to shifting priorities.
- Strong understanding of current GMP/GCP requirements and relevant pharmaceutical regulations.
- Hands-on experience with IRT/RTSM systems (IVR/IWR) — essential.
Core Competencies
- Advanced forecasting and inventory strategy
- Strong grasp of how IRT drives supply movement
- Vendor and cross-functional leadership
- Risk-based thinking
- Strong documentation and inspection-readiness mindset