Associate Director, Regulatory AI Capability Lead

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About the role

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.   Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.   We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description   Key Responsibilities       Regulatory Operations & Process Improvement   • Lead business process mapping, analysis, design, and optimization initiatives across CMC Regulatory Affairs, including development, registration, post-approval, and lifecycle management activities.  • Identify operational pain points, process gaps, inefficiencies, and opportunities for simplification or digital enablement in partnership with process owners and subject matter experts.  • Apply structured problem-solving and data-driven approaches to evaluate root causes, assess options, and develop practical and sustainable solutions.  • Facilitate cross-functional workshops and working sessions to define current and future-state processes, clarify roles and decision points, and establish implementation plans.  • Support the development and maintenance of process standards, procedures, governance mechanisms, and operational controls that enable consistent execution across CMC Regulatory Affairs.  • Develop and monitor operational measures and KPIs to evaluate process performance, adoption, and opportunities for continued improvement  • Support portfolio, resource, and operational planning activities as needed, including use of enterprise planning and resource forecasting tools.     Digital Enablement, Data & Systems   • Partner with the CMC Digital Enablement Head, business process owners, IT, and other stakeholders to identify and advance digital opportunities that address meaningful regulatory business needs.  • Translate regulatory operational needs and process requirements into clear business requirements and use cases for digital, automation, data, and technology solutions.  • Lead or support the implementation of digital solutions from business problem definition and requirements development through testing, deployment, adoption, and continuous improvement.  • Establish and monitor success metrics for digital and AI-enabled capabilities including adoption, operational efficiency, quality, user experience, and business value realization.  • Evaluate opportunities to apply workflow automation, analytics, artificial intelligence, and emerging technologies to improve regulatory processes and decision-making.  • Support integration of regulatory processes, data, content, and systems to enable more connected and efficient ways of working.  • Partner with data and system owners to improve data quality, usability, and availability for regulatory operations, analytics, and decision-making.  • Develop dashboards, metrics, and operational insights that increase visibility into performance and enable dat

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