Executive Director, Clinical Supply Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic and operational guidance for Jade’s Clinical Supply Management function.

• Enhance and expand the team through internal recruitment and external partnerships, which includes hiring, onboarding, and mentoring team members and consultants.

• Establish business processes and standard operating procedures in collaboration with the Quality function.

• Design and implement the clinical supply strategy for programs from Phase 1/2 through Phase 3, with proactive planning for BLA submissions, launches, and commercial readiness.

• Create and manage global demand forecasts and supply plans based on protocols, enrollment forecasts, and site activation schedules.

• Provide counsel to Senior Management and Clinical Operations and Development regarding supply risks and challenges.

• Work collaboratively with Clinical Operations, Clinical Development, Quality, Regulatory Affairs, and CMC.

• Select, contract, and oversee clinical supply CMOs, depots, couriers, logistics providers, and other essential suppliers.

• Supervise the labeling, packaging, blinding, cold-chain storage, and global distribution of drug products.

• Handle comparator sourcing, expiry extensions, relabeling, returns, reconciliation, and destruction.

• Define IRT/IxRS supply needs and resupply strategies; monitor depot and site inventory levels.

• Ensure adherence to SOPs, cGMP, GDP, GCP, ICH guidelines, and global regulatory/import-export mandates.

• Collaborate with Quality on batch release, QP release for EU studies, deviations, and change controls.

• Contribute to IND, IMPD, and CTA regulatory submissions.

• Manage the clinical supply budget effectively.

• Report to stakeholders and senior management regarding inventory, supply and demand, changes, and risks.

⛳️ Requirements

• Bachelor’s or Master’s degree (or equivalent) in Life Sciences, Chemical Engineering, or a related discipline.

• Over 15 years of progressive experience in clinical supply chain management, particularly with biologics, including significant team leadership experience.

• Demonstrated experience managing clinical supply for biologics in vials within cold-chain environments, utilizing both local and multinational CMOs.

• Experience supporting multiple early- and late-stage programs, including multi-country Phase 3 studies and bridging studies for biologic combination products.

• Thorough understanding of global regulatory and import/export requirements across Europe, North America, China, Japan, and the Rest of World (ROW).

• Strong working knowledge of cGMP, GDP, and GCP.

• Practical experience with IRT/IxRS systems, clinical supply forecasting tools, and budget management.

• Proven track record of building and scaling clinical supply functions, including recruiting, onboarding, and managing team members and consultants.

• Outstanding communication, leadership, and interpersonal abilities.

• Strong problem-solving skills and the capacity to excel in a complex, fast-paced clinical development setting.

🏝️ Benefits

• Remote work arrangement.

• Periodic travel to team and company events.