Clinical Supply Chain Manager

Position Summary

The position is responsible for managing supply chain logistics and investigational drug for all clinical studies, in coordination with Clinical Operations, CMC, Regulatory, Quality, and Finance teams. The candidate must have a good understanding of drug development process and be able to independently forecast and manage supply and distribution needs for assigned clinical studies. The ideal candidate will have 5+ years of experience in global clinical supply chain management. This position will report to the Associate Director, Supply Chain.

Key Duties and Responsibilities

• Demand planning and forecasting – able to translate clinical study synopsis/protocols into actionable drug forecasts
• Supply strategies – develop effective packaging and supply strategies maximizing available inventory by location and shelf life while minimizing waste
• Packaging – oversee clinical packaging activities, coordinate release of drug for clinical use
• Inventory Management – manage global depot inventory supporting clinical studies (Phase 1, 2 and/or 3)
• Label text – develop and manage label text, coordinate translations and proofing processes
• Documentation – review/approve vendor packaging, labeling, distribution batch records, protocols, and/or forms, as required
• Distribution and Logistics - manage and monitor global distribution networks based on study requirements, including ensuring required Import/Export documentation is available
• Systems – Implement and manage any required Interactive Response Technology (IRT) supply strategies, review and provide input on User Requirement Specifications (URS) and participate on User Acceptance Tests (UAT) as required
• Effective cross-functional collaborator and communicator. Interface with CMC team, Regulatory Affairs, Quality Assurance, Clinical Operations groups, and others as required to meet project deliverables
• Financial acumen – initiate proposals and purchase orders (POs), manage and approve invoices for CMC Vendors as required
• Vendor management – effective vendor oversight ensuring timelines are met and manage external vendor relationships
• Procedures – develop and establish Standard Operating Procedures (SOP’s) as required
• Shipping Logistics- able to address international import/ export, shipping incoterms, VAT, Tax & Duties queries
• Other activities as required could include managing global shipment and logistics coordination of Drug Substance, Drug Product and other compounds

Qualifications:

• BS/BA degree in related disciplines and at least 5+ years of related experience, unless education and/or work experience exceeds minimum
• Clinical and/or commercial supply chain, planning or materials management, inventory management, and business process facilitation
• Experience with supplying global randomized, blinded studies
• Experience with managing/ approving POs and invoices
• Vendor management experience, specifically with Clinical Packaging and Distribution vendors
• Working knowledge of cGXP’s, familiar with US, EU regulations applicable to investigational drugs and drug development process
• Strong organizational and project management skills, including ability to multitask and organize/track information.
• Demonstrated ability to work independently and with cross-functional teams, including Clinical Operations, CMC, Regulatory, Quality, and Finance teams.
• Customer Service oriented, collaborative and self-starter
• Proficient in Microsoft Outlook, Word & Excel. Excel modeling capabilities a plus
• Business travel may be required (<10%)

The base pay range for this position at commencement of employment is expected to be between $145,000 and $165,000 / year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides, icotrokinra and rusfertide, derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA expected in 2025. Icotrokinra (JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R") which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company. Following icotrokinra's joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered into in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage oral drug discovery programs addressing clinically and commercially validated targets, including the IL-17 oral peptide antagonist PN-881, an oral hepcidin program, and an oral obesity program.