Shawn Silverstein

Background

About Shawn Silverstein

Strategic and results-driven biopharma leader with 18+ years of experience delivering complex, cross-functional Research & Development initiatives. Proven expertise in program leadership, change management, and operational excellence to drive strategy realization and process optimization in matrixed enterprise environments. Adept at accelerating timelines, increasing process efficiency, and leading value-generating organizational transformation — always with a focus on clarity, collaboration, and impact on the business and the patients we serve.Proven Areas of Impact:•Enterprise Strategy Execution: Led initiatives spanning Drug Discovery, Clinical Development, Global Regulatory, Biometrics & Data Sciences, Patient Safety, Medical, and Translational Medicine—driving alignment with enterprise goals.•Operational Efficiency: Delivered hours in annual time savings by automating protocol deviation processes and implementing advanced analytics. Improved clinical data availability to <30 days post-FPFV through vendor alignment and process redesign.•Cost & Compliance Optimization: Achieved $200K+ in yearly savings by streamlining CSR workflows and reducing document publishing volume by 500K+ pages. Successfully led EU Clinical Trial Regulation (EUCTR) compliance transition for 90+ studies—4 months ahead of schedule and faster than industry benchmarks.In both strategy and execution, I bring deep experience in operational excellence, enterprise program management, large-scale transformation, and strategic change execution. Whether building operational infrastructure and KPIs for a new global site, standing up crisis response task forces, or improving operating models and cross-functional governance, I prioritize clarity, efficiency, and partnership. My ability to engage stakeholders, align on strategy, and deliver fit-for-purpose solutions has helped enhance decision-making, reduce cycle times and cost, and cultivate a culture of continuous improvement and collaboration.