Experienced and professional Manger of Supply Chain who will be responsible for managing the GMP inventory and global logistics at Viking’s San Diego site. The Manager of Clinical Supply Chain will report to the Director of Clinical Supply Chain. The position is highly cross-functional and will work with Quality Control, Quality Assurance, CMC, development team, regulatory, and external vendors.  The Sr Manager of Clinical Supply Chain will represent Supply Chain function for Viking to define and operationalize Supply Chain system, to support clinical material manufacturing globally, and to determine distribution strategy for the lifecycle of products from pre-IND through post launch. 

Essential Duties And Responsibilities

The main responsibilities of this role include but are not limited to the following:

• 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

• 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. 

• 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. 

• 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.

VIKING THERAPEUTICS

Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Notice to Agency and Search Firm Representatives

Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.