Study Optimization Manager

The Study Optimization Manager (SOM) role is accountable for the development, implementation and oversight of optimal clinical supply strategies using advanced modeling techniques and software for selected high-value clinical trials. This R&D enterprise responsibility impacts optimal design of clinical trials, acceleration of clinical supply, and oversight of strategic, enterprise-level risk mitigation and supply management.

• Apply strategic, cross-program knowledge of clinical supplies to positively influence clinical trial design and supply chain decisions.
• Accountable for independent development and management of advanced demand and supply models in the N-Side Supply Application or other appropriate tools.
• Builds understanding of the business context, systems, environment, strategy and people assigned to the given area. This also includes an understanding of the relevant and complex internal and external high-volume data sources, validity and domains of such data to align with the intended business objective.
• Leads the creation of required data sets, utilizing understanding of complex business problems, data formats, applicability of the data to the problem and standard modelling techniques. Performs & oversees techniques to validate the quality of the data, and fuse data sources using knowledge of data pre-processing techniques for complex or large-scale use cases. Identify and access novel internal and external data sources, while ensuring compliance with data security and privacy requirements.
• Utilizes basic and advanced modeling techniques, such as basic statistical methods, predictive modelling, advanced clustering, association rules to create models that perform to particular requirements and specifications. Anticipates how a model's requirements or the available data, will change over time and designs a product that will be able to cope with these requirements. Brings knowledge and expertise about best practices and current future-focused trends and techniques for data modelling and has experience in delivering solutions to production via Continuous Integration / Continuous Delivery.
• Designs rich data visualizations and uses them to communicate complex messages to business leaders at all levels of the organization in a clear and simple way, with the ability to respond effectively to highly challenging questions.
• Proactively engages with internal stakeholders (Clinical Development, Clinical Operations, Value Evidence and Outcomes, Biostats, Comparators Team, Medicine Development & Industrialization) to obtain needed inputs.
• Ensures optimal supply strategy is identified for assigned studies to include comparators, randomization, blinding, country pre-selection and IRT design requirements.
• Optimizes supply strategies initially and dynamically over the duration of the study to mitigate risk, maximize utilization and identify, assess and act on value opportunities to allow the organization to realize monetary savings and redirect capital to support the R&D pipeline.
• Leads cross-functional matrixed forecasting, planning and scheduling of portfolio working in conjunction with respective CSC WSL / Supply Chain Managers, Planners, and Supply Chain Study Leads.
• Proactively identifies and communicates issues as well as provides proposed solutions.
• Aligns supply strategies across CMC, PM, Regulatory, Analytical, Quality, and CSC.
• Performs monthly assessment of the supply plan impact at the asset and portfolio level, in conjunction with the CSC Demand and Operations Planning cycle.
• Provides ongoing visibility of projected study supply performance, costs and risk levels with clear recommendations for improvement.
• Drives application of value criteria and prioritization of the clinical trial portfolio for identification of advanced demand modeling targets.
• Defines processes for required data integration with Intel Hub, IRT, fusion, and other data platforms.
• Develops and maintains process documentation and data governance standards for advanced demand modeling.

• Bachelor's degree in pharmacy, Chemistry, Biology, Engineering, Supply Chain, Logistics, Statistics,…