Clinical Supply Chain Manager

Nura Bio; South San Francisco (CA); Hybrid; USD 140,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) plan with company match

Stock options

Job summary

Nura Bio, Inc. in South San Francisco is seeking a Manager/Sr. Manager of Supply Chain to lead global supply, forecasting, and logistics for clinical studies. The role collaborates with Clinical Operations, CMC, Regulatory, QA, and Finance to ensure uninterrupted drug availability and compliant distribution.

The position requires strong planning, vendor management, and experience with investigational drugs, with onsite presence three days per week at the South SF office.

Qualifications

• BS/BA degree in related disciplines.
• 5+ years of related experience in supply chain for clinical studies.
• Experience in clinical and/or commercial supply chain, planning or materials management.
• Experience with global randomized, blinded studies.
• Experience with managing POs and invoices.
• Vendor management with clinical packaging and distribution vendors.
• Familiar with cGXP and US/EU regulations for investigational drugs.
• Strong organizational and project management skills.
• Ability to work independently and cross-functionally.
• Proficient in Microsoft Outlook, Word & Excel; Excel modeling a plus.
• Business travel may be required (<10%).

Responsibilities

• Demand planning and forecasting for clinical studies.
• Develop packaging and supply strategies by location and shelf life.
• Oversee clinical packaging activities and release of drug for clinical use.
• Manage global depot inventory supporting clinical trials (Phase 1–3).
• Develop and manage label text; coordinate translations and proofing.
• Review vendor packaging, labeling, batch records and related forms.
• Manage global distribution networks and required import/export documentation.
• Implement and manage IRT supply strategies; contribute URS/UAT input.
• Collaborate cross-functionally with CMC, Regulatory, QA, and Clinical Ops.

Skills

Supply chain management

Forecasting

Clinical packaging

Vendor management

PO and invoices

cGXP/regulatory knowledge

Project management

Cross-functional collaboration

Microsoft Excel modeling

Travel (<10%)

Education

BS/BA degree

Job description

Nura Bio, Inc. (Nura Bio) is a clinical-stage biopharmaceutical company developing neuroprotective therapies for the treatment of a broad range of neurological diseases. Nura Bio's research and early development small molecule pipeline is focused on developing therapies that halt axon degeneration and/or modulate microglial responses to degeneration and injury, with the goal of conferring neuroprotection, across diseases of the central, peripheral, and ocular nervous system.

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 drug development process and be able to independently forecast and manage supply and distribution needs for assigned clinical studies. This position will report to VP, CMC and be onsite 3 days a week at our South SF office.

Key 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
• Other activities as required could include managing global shipment and logistics coordination of Drug Substance, Drug Product and other compounds

Qualifications & Skills:

• 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%)

Manager and Sr. Manager levels, allowing us to consider candidates with a range of relevant experience and expertise. The final level and title offered will be determined based on the selected candidate's depth of experience, functional and subject-matter expertise, demonstrated capabilities, and overall evaluation throughout the interview process. The scope of responsibilities, level of ownership, and final title will be commensurate with the candidate's qualifications and the needs of the role.

Nura Bio offers a comprehensive and generous benefits package, including medical, dental, and vision insurance, life and disability insurance, health savings and flexible spending accounts (including dependent care), a 401(k) plan, and highly attractive stock options.

Nura Bio is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

To learn more about our mission and our science, visit us at www.nurabio.com.