Executive Director, Clinical Supply Management

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $280k - $300k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

👻 Ghost score 1%

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Logo of Jade Biosciences

Jade Biosciences

11 - 50 employees

Founded 2024

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jade Biosciences is a clinical-stage biotechnology company developing potentially best-in-class therapies aimed at transforming the standard of care for autoimmune diseases. Its lead candidate, JADE101, is an antibody designed to inhibit the cytokine APRIL (A PRoliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN). The company builds its pipeline from discovery-stage assets licensed from Paragon Therapeutics and is focused on advancing clinical programs to deliver new treatments for patients with autoimmune conditions.

📋 Description

• Provide strategic and operational leadership for Jade’s Clinical Supply Management function • Develop and scale the team through internal headcount and external partners, including recruiting, onboarding and mentoring team members and consultants • Develop business processes and SOPs with the Quality function • Define and implement clinical supply strategy for programs from Phase 1/2 through Phase 3, with forward planning for BLA filing, launch and commercial readiness • Build and maintain global demand forecasts and supply plans based on protocols, enrollment projections and site activation plans • Advise Senior Management and Clinical Operations and Development on supply risks and challenges • Collaborate with Clinical Operations, Clinical Development, Quality, Regulatory Affairs and CMC • Select, contract and manage clinical supply CMOs, depots, couriers, logistics providers and other critical suppliers • Oversee labeling, packaging, blinding, cold-chain storage and global distribution of drug products • Manage comparator sourcing, expiry extensions, relabeling, returns, reconciliation and destruction • Define IRT/IxRS supply requirements and resupply strategies; monitor depot and site inventory • Ensure compliance with SOPs, cGMP, GDP, GCP, ICH guidelines and global regulatory/import-export requirements • Partner 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 • Report to stakeholders and senior management on inventory, supply and demand, changes and risks

🎯 Requirements

• Bachelor’s or Master’s degree (or equivalent) in Life Sciences, Chemical Engineering or a related field • 15+ years of progressive experience in clinical supply chain management, ideally with biologics, including significant experience leading teams • Proven experience managing clinical supply for biologics in vials within cold-chain environments, using 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 • Comprehensive understanding of global regulatory and import/export requirements across Europe, North America, China, Japan and Rest of World (ROW) • Strong working knowledge of cGMP, GDP and GCP • Hands-on experience with IRT/IxRS systems, clinical supply forecasting tools and budget management • Demonstrated success building and scaling clinical supply functions, including hiring, onboarding and managing team members and consultants • Exceptional communication, leadership and interpersonal skills • Strong problem-solving skills and ability to thrive in a complex, fast-paced clinical development environment

🏖️ Benefits

• Remote work arrangement • Periodic travel to team and company events

Apply Now

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