We are looking for a Project Manager, Clinical Supply Chain who will be responsible for leading the global design and set up of end to end customized clinical supply chains in support of the assigned clinical programs/studies in a timely, efficient, effective and independent manner.
This role is also responsible for partnering with several cross functional stakeholders such as early development, global development organization, global regulatory and product development teams, device engineering, clinical artwork team and clinical demand and inventory planning team.
In addition, the Project Manager, Clinical Supply Chain will ensure supply for global clinical trial to support first subject enrolled plus provide robust inventory management tools for the clinical demand and inventory planning team
• Develop and employ project management techniques to design and set up supply chains for clinical studies. This includes:
• Create and maintain project plan to ensure timely clinical study start to support first subject enrolled
• Create and maintain study forecast for finished drug product in applicable systems to support clinical study start
• Design optimal packaging configuration for finished drug product taking into account protocol requirements and product characteristics.
• Ensure storage and shipping capabilities plus sufficient capacity for finished drug product is available within the supply chain network (both internal and external) to support global study footprint.
• Design cost efficient (re)supply model to distribute finished drug product via applying risk analysis and mitigation strategy.
• Ensure efficient and smooth hand-over to clinical demand and inventory planning team
• Facilitate the phase in phase out strategy for new medicinal product introduction, such as running scenario’s, impact on study demand and set up activities for formulation and device introductions
• Performs other functions as assigned
OR Master’s degree and 2 years of logistics, business administration or life science experience
Bachelor’s degree and 4 years of logistics, business administration or life science experience
Associates degree and 10 years of logistics, business administration or life science experience
High school diploma / GED and 12 years of logistics, business administration or life science experience
• Knowledge of clinical supply chain management
• Bachelor’s degree or equivalent in logistics, business administration or life science.
• 5 year’s relevant working experience, preferably in the biotechnology or pharmaceutical industry, with an in-depth knowledge of supply chain management and clinical research management principles.
• At minimum 5 year experience in project leadership and project management techniques in an international and regulated environment
• General understanding of regulatory guidelines impacting clinical supplies (i.e. GxP, ICH guidelines, Clinical Trial Directive)
• Fluency in English, both verbal and written communication
• Advanced experience in MS Office applications
• Experience in using ERP systems, preferably SAP
• Project Management certification (PMP, IPMA)