Viking Therapeutics, Inc. · 2 months ago
Manager, Clinical Supply Chain
Viking Therapeutics, Inc. is a biotechnology company focused on developing innovative therapies. They are seeking a Manager of Clinical Supply Chain to oversee GMP inventory and global logistics, ensuring efficient supply chain operations for clinical trials.
Health CareMedicalTherapeutics
Responsibilities
With minimal supervision, manage and support investigational drug product supply and logistics activities, including, but not limited to, 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 of 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 the origination, proofing, and translation of clinical study labels and generation
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 (including, but not limited to, CMC, Clinical Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)
Support temperature excursion processes are executed as required
Support IRT System development. Lead development of user requirement specifications and management module(s) as applicable
Various other duties as assigned
Qualification
Required
Bachelor's 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 (permits, licenses, declaration letters) 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 as well as regulatory regulations and compliance 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, specifically in the biotech/pharma/consumer goods industries
Strong computer skills with Microsoft Office and the ability to quickly learn new applications
Team player with demonstrated strong communication skills, interpersonal skills, and ability to build effective working relationships throughout all levels of the organization
Preferred
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, dynamic, and highly fluid company environment with minimal direction and able to adjust workload based upon changing priorities
Company
Viking Therapeutics, Inc.
Viking Therapeutics, Inc.
Funding
Current Stage
Public CompanyTotal Funding
$1.06B2024-02-28Post Ipo Equity· $632.5M
2023-03-29Post Ipo Equity· $250M
2018-06-12Post Ipo Equity· $140.9M
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