Clinical Supply Chain Manager

About the role

Nura Bio, Inc. is a clinical-stage biopharmaceutical company developing neuroprotective therapies for the treatment of a broad range of neurological diseases. We are seeking a Manager/Sr. Manager of Supply Chain to lead and oversee 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 the drug development process and be able to independently forecast and manage supply and distribution needs for assigned clinical studies. This position will report to the VP of CMC and requires onsite presence 3 days a week at our South San Francisco office.

Responsibilities

• Demand planning and forecasting – translate clinical study synopsis/protocols into actionable drug forecasts.
• Develop effective packaging and supply strategies to maximize available inventory by location and shelf life while minimizing waste.
• Oversee clinical packaging activities and coordinate the release of drug for clinical use.
• Manage global depot inventory supporting clinical studies (Phase 1, 2, and/or 3).
• Develop and manage label text, coordinate translations, and proofing processes.
• Review and approve vendor packaging, labeling, distribution batch records, protocols, and/or forms as required.
• Manage and monitor global distribution networks based on study requirements, including ensuring required import/export documentation is available.
• Implement and manage Interactive Response Technology (IRT) supply strategies; review and provide input on User Requirement Specifications (URS) and participate in User Acceptance Tests (UAT) as required.
• Serve as an effective cross-functional collaborator and communicator, interfacing with CMC, Regulatory Affairs, Quality Assurance, Clinical Operations, and other teams to meet project deliverables.
• Demonstrate financial acumen by initiating proposals and purchase orders (POs), and managing and approving invoices for CMC vendors.
• Provide effective vendor oversight to ensure timelines are met and manage external vendor relationships, particularly with Clinical Packaging and Distribution vendors.
• Develop and establish Standard Operating Procedures (SOPs) as required.
• Address international import/export, shipping incoterms, VAT, tax, and duties queries.
• Manage global shipment and logistics coordination of Drug Substance, Drug Product, and other compounds as needed.

Requirements

• BS/BA degree in related disciplines and at least 5+ years of relevant experience (unless education and/or work experience exceeds the minimum).
• Experience in clinical and/or commercial supply chain, planning, materials management, inventory management, and business process facilitation.
• Experience with supplying global randomized, blinded studies.
• Experience managing and approving POs and invoices.
• Vendor management experience, specifically with Clinical Packaging and Distribution vendors.
• Working knowledge of cGXPs and familiarity with US and EU regulations applicable to investigational drugs and the drug development process.
• Strong organizational and project management skills, including the 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.
• Customer service-oriented, collaborative, and self-starter.
• Proficient in Microsoft Outlook, Word, and Excel (Excel modeling capabilities a plus).
• Business travel may be required (<10%).

The title of this position encompasses both the Manager and Sr. Manager levels, allowing consideration of candidates with a range of relevant experience. The final level and title will be determined based on the selected candidate’s depth of experience, functional and subject-matter expertise, demonstrated capabilities, and overall evaluation during the interview process.

Benefits

• Comprehensive medical, dental, and vision insurance.
• Life and disability insurance.
• Health savings and flexible spending accounts (including dependent care).
• 401(k) plan.
• Highly attractive stock options.