SK Life Science, Inc. · 1 week ago
Clinical Supply Chain Manager
US-NJ-Paramus
Full-time
Onsite
Mid, Senior Level
5+ years expSK Life Science, Inc. is seeking a Clinical Supply Chain Manager responsible for the end-to-end strategic planning and operational execution of clinical trial material supply chains. This role involves managing global CDMOs, ensuring compliance with GxP regulations, and overseeing IRT systems to support clinical studies.
BiotechnologyPharmaceutical
Responsibilities
Aggregate and quantify future requirements for clinical trial materials into a comprehensive supply/demand forecast at program and study levels, to develop CTM project plan and integrate the plan with clinical trial timeline by conducting capacity planning and inventory control to create supply and distribution plans
Collaborate with Clinical Operations to align supply forecasts with real-time patient enrollment data
Manage or supervise distribution/logistics activities of complex supply chains globally, by evaluating worldwide subject screening and enrollment progress, inventories at sites and depots, tracking expiry dates, initiating shipments, coordinating import/export requirements
Proactively identify potential supply chain risks (e.g., shipping delays, production failures, or temperature excursions) and develop contingency plans to minimize impact on clinical timelines
Prepare Requests for Proposals for activities in support of clinical supply projects
Identify the most suitable CRO/CMO and initiate contracts. Oversee work assignment and deliverables for CTM suppliers and ensure timely completion of CTM milestones and internal development work. Manage and track CTM vendor contract, purchase orders, work orders, and invoices
Provide technical support for vendor’s IRT system in support of SK clinical studies
Monitor and manage real-time clinical supply inventories and site-level stock through Interactive Response Technology (IRT) from study start-up through closure
Analyze IRT reports to identify enrollment trends and proactively adjust site-level buffer limits to prevent stock-outs while minimizing waste
Participate in the execution of User Acceptance Testing (UAT) for IRT supply modules to verify system logic for randomization, kit assignment, and resupply triggers
Assist to ensure accurate IRT data transfers for monthly reconciliation and maintain essential system documentation to ensure Trial Master File (TMF) and inspection readiness
Consult on clinical study protocol, suitable CTM development and supportive stability plan, comparator sourcing, and clinical site selection. Lead cross-functional CTM supply team. Conduct CRA training for CTM supply
Assist and support in writing and preparation of SOPs and interpreting and reviewing SOPs and study protocols
Review manufacturing, packaging, and labeling Master and Executed Packaging Work Orders/Batch Records (MBR/EBR, Packaging Labeling Approval Forms (PLAF), Labeling Approval Forms (LAF), etc
Assist in the maintenance of SOPs related to reflecting current clinical supply activities. Assist and support Investigational Product Accountability, Returns, Reconciliation and Destruction at the end of the studies and collect all necessary documentation from vendors
Actively monitor the budget for individual study supply activities and materials for assigned projects. Maintain the cost trackers, invoices etc. Prepare and assist the FP&A team on project-specific spending and accrual monthly and quarterly basis, if requested
Participate in project budgeting and forecasting process for the CMC Team’s annual project budget management activities
Qualification
Required
Bachelor's degree in Pharmacy or related science and/or Supply Chain with 5-10 years of experience in the pharmaceutical industry with a focus in clinical supplies
Expert technical skills, good organization skills, ability to follow directions, and good communication skills
Proficiency with Microsoft Office, and in particular use of Excel and the ability to plot data
Understand protocols and have technical knowledge of packaging and labeling activities
Knowledge of pharmaceutical stability protocols, assessment of expiration dating for investigational drug products
Knowledge of GMP batch record development, review, and approval process
Demonstrated understanding of the entire supply chain and associated cost drivers
Ability to execute the Clinical Supply portion of User Acceptance Testing (UAT) for the IRT system
Knowledge of GCP and global cGMP regulations
Knowledge of warehousing, distribution (including cold chain distribution), and logistics
Ability to review, analyze, and interpret the IRT reports and specification requirements
Ability to understand, maintain, and demonstrate troubleshooting on vendor's IRT system
Ability to multitask
Adapts to change
Maintains composure under pressure
Ability to follow verbal and/or written instructions
Use of effective verbal communications
Grasps information quickly
Examines and observes details
Ability to work in a multi-cultural environment
Preferred
Knowledge of EU GMP QP regulations
Company
SK Life Science, Inc.
SK Life Science, Inc., a U.S. subsidiary of SK Biopharmaceuticals, stands at the forefront of innovation in healthcare.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Hong-Wook Kim
Vice President & Chief Operating Officer
Christine Mapes
CMO Manager, Supply Chain
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