Manager, Clinical Supply Chain

Role Summary

Manager, Clinical Supply Chain at Viking Therapeutics. Responsible for managing GMP inventory and global logistics at the San Diego site, collaborating across Quality Control, Quality Assurance, CMC, development, regulatory, and external vendors. Defines and operationalizes the Supply Chain system to support clinical material manufacturing globally and determines distribution strategy across the product lifecycle from pre-IND through post-launch.

Responsibilities

• With minimal supervision, manage and support investigational drug product supply and logistics activities, including demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, returns, reconciliation, destruction, cold chain management, and inventory management
• Monitor inventory levels ensuring no shortage of IMP throughout the life of a clinical trial
• Manage packaging and labeling/distribution vendors, including relationship management
• Manage preparation of clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, coordinating origination, proofing, and translation of clinical study labels
• Proactively identifying potential issues and developing mitigating actions
• Interpret clinical synopses and protocols to create clinical IMP demand forecasts
• Attend clinical study and cross-functional meetings as needed
• Oversee the execution of multiple clinical trials and proactively identify potential supply chain issues and recommend solutions to global supply chain
• Manage clinical study close-out activities, including returned goods, reconciliation, and inventory destruction
• Support drug supply delivery through coordination of CMC efforts across multiple functions
• Support temperature excursion processes as required
• Support IRT System development and lead development of user requirement specifications and management module(s) as applicable
• Various other duties as assigned

Qualifications

• Bachelor‚Äôs degree in Chemistry, Pharmacy or other relevant discipline
• 6+ years of industry experience in Supply Chain Operations
• Significant experience with global shipping and logistics of materials
• Experience working in an FDA-regulated environment is required
• Experience with establishment and maintenance of GMP quality-controlled storage
• Direct experience with importing/exporting documentation for global distribution of live virus banks, cell banks, and raw materials
• Direct experience with 3rd party vendors for shipping/logistics service
• Knowledgeable with cGxP regulatory requirements for the pharmaceutical industry
• Experience in reviewing and authoring SOPs related to CMC Clinical supply chain
• Experience in organizing and management of GMP warehouse inventory
• Experience with Inventory Management Systems is a plus
• Technical working knowledge and/or experience in product packaging or design a plus
• Comfortable in a fast-paced environment with minimal direction and ability to adjust workload
• Strong computer skills with Microsoft Office and ability to learn new applications quickly
• Team player with strong communication and interpersonal skills

Skills

• Cross-functional collaboration
• Forecasting and demand planning
• GMP inventory management
• Regulatory compliance (FDA, cGxP)
• Vendor management
• Process development and documentation
• IRT system knowledge
• Analytical thinking and problem solving

Education

• Bachelor‚Äôs degree in Chemistry, Pharmacy or related field