Senior Manager, Clinical Supply Chain

General Description:

The Sr Manager of Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, and distribution for one or more clinical studies. Actively develops and oversees supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste. Represents Clinical Supply Chain to internal stakeholders and manages relationships with external supply partners. Has working knowledge of clinical supply best practices, IRT systems, as well as experience working within a cGMP environment. Works with management to develop and implement process improvements to build the organization for the future.

Essential Functions:

• Represent the Clinical Supply Chain on Clinical Study Teams (CST) and provide a high service level to internal stakeholders (e.g. Clinical Operations, Regulatory, Quality, CMC).

• Work with Clinical Operations to understand clinical demand requirements and ensure alignment with study teams to supply plans and timelines.

• Create supply and inventory plans and develop production schedules for clinical trial materials.

• Monitor schedule adherence of production schedules and make course corrections if needed.

• Manage GMP inventory throughout the supply chain, develop inventory reports, manage upcoming expiry, and ensure drug accountability.

• Manage the relationship and oversee daily activities for FG label & pack CMOs and distribution vendors.

• Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure.

• Ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s).

• May coordinate review and approval of labels with stakeholders (e.g. Regulatory, Clinical Operations, CRO) and CMOs.

• Support IRT user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply activities in system.

• Coordinate and track bulk shipments to CMOs, depots, and vendors. Maintain and track import licenses.

• Develop supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans

• Lead cross functional projects and process improvements related to drug supply.

• Creates and/or revise process documents such as Standard Operating Procedures.

• Additional responsibilities as required.

• Ensure staff who are in supportive roles for supply planning and business process development are meeting deliverables for successful study management

Education/Experience Required:

• Bachelor's or Master's degree in Business Administration, Operations Management, or a related field required.

• Minimum of 7 years of progressive experience in supply chain, preferably within the biotech, pharmaceutical, or CRO industry.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.