Sr. Manager, Supply Chain

Sr. Manager, Supply Chain

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 Senior 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 7+ 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 $140,000 and $170,000/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 biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and Janssen scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with Janssen and followed it through IND-enabling pre-clinical and Phase 1 studies, with Janssen assuming responsibility for further clinical development. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development program. The randomized portion of the Phase 2 REVIVE study was unblinded, showing positive results and is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Protagonist retains all worldwide development and commercialization rights to rusfertide.