Manager / Sr. Manager Clinical Supply Chain

BeiGene

4d•$131,800 - $176,800

About The Position

The Manager / Senior Manager, Clinical Supply Chain manages drug-supply activities for one or more clinical studies, including planning, label development, labeling and packaging, and distribution. The role develops and oversees supply plans to maintain accurate, continuous patient supply while reducing risk and minimizing waste. It represents Clinical Supply Chain to internal stakeholders and manages relationships with external supply partners. The position requires working knowledge of clinical supply best practices and IRT systems, along with experience in a cGMP environment. The role also works with management to develop and implement process improvements and oversees deliverables from staff supporting supply planning and business-process development.

Requirements

Bachelor’s or master’s degree in Business Administration, Operations Management, or similar education.
At least 7 years of progressive experience in Clinical Supply Chain, preferably in the biotech, pharmaceutical, or CRO industry.
Working knowledge of clinical supply best practices and IRT systems.
Experience working within a cGMP environment.

Responsibilities

Represent Clinical Supply Chain on Clinical Study Teams and provide a high level of service to internal stakeholders, including Clinical Operations, Regulatory, Quality, and CMC.
Work with Clinical Operations to understand clinical demand requirements and align supply plans and timelines with study teams.
Create supply and inventory plans and develop production schedules for clinical trial materials.
Monitor production-schedule adherence and make course corrections when needed.
Manage GMP inventory throughout the supply chain, develop inventory reports, manage upcoming expiries, and ensure drug accountability.
Manage relationships with, and oversee daily activities of, finished-goods labeling and packaging CMOs and distribution vendors.
Investigate exceptions, determine root causes, implement CAPAs, and drive them to closure.
Ensure label text and proofs comply with applicable rules, regulations, product specifications, and clinical study protocols.
Coordinate label review and approval with stakeholders such as Regulatory, Clinical Operations, CROs, and CMOs, as needed.
Support IRT user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply activities in the system.
Coordinate and track bulk shipments to CMOs, depots, and vendors, and maintain and track import licenses.
Develop supply strategies that maximize efficiency and minimize waste, identify risks, and develop mitigation plans.
Lead cross-functional drug-supply projects and process improvements.
Create and revise process documents such as Standard Operating Procedures.
Ensure staff in supportive supply-planning and business-process-development roles meet deliverables for successful study management.
Perform additional responsibilities as required.