Manager, Clinical Supply Chain

The Opportunity:

The Manager serves as the clinical supply chain lead for assigned clinical studies and ensure uninterrupted clinical trial supply. This position partners closely with Clinical Operations, product lead, Regulatory Affairs, Quality Assurance, Project Management, and external vendors to support the successful execution of global clinical studies while maintaining compliance, inspection readiness, and operational excellence.

Responsibilities:

• Serve as the clinical supply lead for assigned study(s) and develop/manage the clinical supply Develop and execute comprehensive clinical supply strategies for global clinical development programs from Phase I through Phase III, ensuring alignment with program objectives, enrollment assumptions, manufacturing timelines, and regulatory requirements.

• Lead demand forecasting, supply planning, inventory management, and scenario analysis to ensure continuous product availability while minimizing waste and supply risk.

• Execute global packaging, labeling, and distribution, ensuring compliance with country-specific requirements and efficient supply to clinical sites worldwide.

• Support IRT/RTSM systems, including development of user requirements, execution of user acceptance testing, implementation of supply strategies, change controls, and ongoing system maintenance.

• Review and approve clinical supply chain documentation including clinical label text, batch records, pharmacy manuals, protocols. Support INDs, IMPDs, and other regulatory submissions as applicable.

• Facilitate vendor selection, qualification, contracting, and performance management activities for packaging vendors, depots, logistics providers, comparator sourcing vendors, and other external partners.

• Develop and implement risk management strategies to proactively identify and mitigate supply chain risks that could impact study timelines or patient enrollment.

• Represent Clinical Supply Chain on cross-functional program teams and governance committees, providing strategic recommendations and decision-making support.

• Develop and manage study level clinical supply budgets, vendor forecasts, and operational expenditures.

• Facilitate continuous improvement initiatives and establish scalable processes, systems, and metrics to support organizational growth.

• Participate in author, review, approve, and maintain SOPs, work instructions, and business processes related to clinical supply chain operations.

Required Skills, Experience and Education: 

• Bachelor’s or Master’s degree in Supply Chain, Life Sciences, Pharmacy, Engineering, or a related scientific discipline with a minimum of five years of relevant pharmaceutical or biotechnology industry experience. Demonstrated experience managing global clinical supply chains supporting Phase I through Phase III clinical trials is required.

• Candidates must possess knowledge of clinical supply planning, forecasting, inventory management, packaging, labeling, distribution, and clinical logistics. Strong experience managing external vendors, depots, distribution centers, and logistics providers is essential.

• The successful candidate will have a thorough understanding of GCP, GMP, GDP, ICH guidelines, and global regulatory requirements governing clinical trial materials. Strong leadership, communication, organizational, analytical, and project management skills are required, along with experience working effectively across complex cross-functional organizations.

• Experience with IRT/RTSM systems, inventory management systems, ERP platforms, and clinical supply planning tools is required.

Preferred Skills:

• Experience supporting oncology clinical development programs is preferred. Additional experience supporting late-stage development, comparator sourcing, combination therapy studies, commercial readiness activities, and global cold-chain distribution is highly desirable.

• Experience implementing clinical supply systems, driving process improvements, and leading or mentoring supply chain professionals in a growing biotechnology environment is also preferred.

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