Specialist Clinical Supply Chain - Planner• Translate Clinical Development requirements into an actionable supply plan
• Strategize with study managers and review study protocols to determine appropriate packaging configurations, blinding techniques, and optimal distribution plans
• Lead forecasting efforts, including key stakeholder meetings, to ensure the adequacy of supply/re-supply strategies and negotiate resolution of resource conflicts where necessary and actively participate in planning meetings to ensure that project needs, priorities, and timing are understood
• Serve as the primary interface with Clinical Development, Quality, Biostatistics, Regulatory Affairs, Corporate Planning, and Operations to ensure coordination of all activities necessary to develop the forecast and ensure an adequate supply plan
• Resolve logistical conflicts impacting studies and R&D milestones ensuring that supplies are not on the critical path and assess issues with regards to study design, supply availability, and timelines
• Provide input to matrix teams on timing, resourcing, and budget projections and determine distribution strategies for global studies
• Coordinate labeling, packaging, and shipment of packed supplies
• Promptly identify and escalate risks to study timelines or clinical supplies, from a supply chain perspective, to all key stakeholders and internal management
• Utilize systems to effectively manage key product/project activities
• Oversee identification, appropriate provision and presentation of comparator agents to meet study requirements
• Articulate clinical supply chain management processes and strategies to key stakeholders
• Review and update existing procedures and SOPs; identify the need for and assist in the establishment of new procedures and SOPs
Basic Qualifications
• Doctorate degree
OR
• Master's degree & 3 years of directly related experience
OR
• Bachelor's degree & 5 years of directly related experience
OR
• Associate's degree & 10 years of directly related experience
OR
• High school diploma / GED & 12 years of directly related experience
Preferred Qualifications
Advanced degree in Life Sciences, Engineering or Business
5 + years of work experience in the planning, manufacturing and global distribution of medicinal products
3 + years organizational or program management (leading teams, cross-functional problem solving, performance management, budget oversight, process development and improvement)
Additional 3 + years of work experience in clinical study design, management, approval, supply and management
APICS CPIM/CIRM certification
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