US Clinical Operations Consultant / Supply Chain Expert (SE S00207)

We are looking for an experienced Operations Consultant / Supply Chain Expert to support a commercialization project for a new at-home diagnostic test in the cancer screening space. The consultant will play a key role in designing and validating a scalable, compliant, and user-friendly logistics infrastructure that enables patients to easily receive, use, and return breath sample collection kits from their homes.

This role is ideal for someone with hands-on experience managing end-to-end supply chains for diagnostic products — especially those involving direct-to-consumer distribution and at-home sample return.

🔄 End-to-End Supply Chain Design

•     Develop a comprehensive operational plan from kit production to patient delivery and return logistics.
•     Help define and document SOPs across the entire physical workflow — including high-volume scaling (1M+ samples/year).

📦 Kit Logistics & Packaging

•     Advise on packaging materials and structure to ensure sample protection and shipping efficiency.
•     Recommend solutions for environmental stressors like temperature and humidity — critical for sample integrity during validation and shipping.

🚚 Reverse Logistics & Sample Integrity

•     Design and optimize the return process from the patient’s home to the CLIA-certified lab.
•     Propose or validate systems for sample tracking and monitoring, with a focus on transit time, stability, and chain-of-custody.

📊 Inventory Management & Forecasting

•     Build a scalable approach to kit inventory tracking, material restocking, and demand forecasting across distribution points.

⚖️ Operational Compliance & Quality Assurance

•     Ensure compliance with regulations related to shipping biological materials and medical devices.
•     Define quality control checkpoints to prevent sample loss, damage, or delay.

🤝 Vendor & Partner Coordination

•     Help source and evaluate third-party logistics providers, packaging vendors, and fulfillment partners.

• 7+ years of experience in operations, logistics, or supply chain roles within diagnostics or healthcare industries.
• Proven track record with at-home sample collection and return logistics (e.g., saliva, blood, breath, or stool kits).
• Strong understanding of direct-to-consumer distribution models in healthcare.
• Experience specifically in cancer screening or diagnostics is highly preferred.
• Working knowledge of U.S. regulations governing CLIA labs, LDTs, and IVDs — particularly regarding packaging, shipping, and labeling of diagnostic kits.
• Ability to work independently, assess operational risks, and offer practical, scalable solutions.

• Previous consulting or advisory experience a plus, but not required.