Manager, Senior Manager – Clinical Supply Chain

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the drug supply activities for one or more clinical programs, which includes planning, label development, packaging, and distribution.

• Create and manage supply plans to guarantee a consistent patient supply while minimizing risks and reducing waste.

• Act as a representative of the Clinical Supply Chain within Clinical Study Teams, providing support to internal stakeholders such as Clinical Operations, Regulatory, Quality, and CMC.

• Collaborate with Clinical Operations to ascertain clinical demand needs and synchronize supply plans and timelines.

• Formulate supply and inventory plans while developing production schedules for clinical trial materials.

• Track adherence to production schedules and implement necessary adjustments.

• Manage GMP inventory, generate inventory reports, monitor upcoming expirations, and ensure accountability of drugs.

• Supervise the daily operations of finished-goods labeling, packaging CMOs, and distribution vendors.

• Analyze exceptions, identify root causes, implement CAPAs, and ensure resolution.

• Verify that label text and proofs adhere to relevant rules, regulations, product specifications, and clinical study protocols.

• Facilitate label review and approval processes with Regulatory, Clinical Operations, CROs, and CMOs.

• Assist in IRT user acceptance testing and establish an IRT supply strategy, including DNX parameters.

• Organize and monitor bulk shipments to CMOs, depots, and vendors; manage import licenses.

• Create supply strategies, identify potential risks, and develop risk mitigation plans.

• Assist with functional projects and enhancements in the drug supply process, including the creation or revision of SOPs.

• Ensure that supporting staff achieve deliverables necessary for successful study management.

⛳️ Requirements

• A bachelor's or master's degree in business administration, Operations Management, or a related field is required.

• A minimum of 5 years of progressive experience in supply chain management, preferably in the biotech, pharmaceutical, or CRO sector.

• Familiarity with clinical supply best practices is essential.

• Experience with IRT systems is required.

• Experience in a cGMP environment is necessary.

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

• Understanding of applicable rules, regulations, product specifications, and clinical study protocols related to labeling.

• Proficiency in investigating exceptions, identifying root causes, implementing CAPAs, and ensuring closure.

• Ability to coordinate and track shipments while maintaining import licenses.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Eligibility for an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• FSA/HSA options.

• Life insurance.

• Paid Time Off.

• Wellness programs.