Executive Director of Clinical Data Engineering & Analytics (CDEA)
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Responsibilities
- Develop and implement a forward-looking clinical and early programming innovation vision and strategy, streamlining processes and integrating modern technologies-AI, machine learning, automation, visual analytics and cloud computing-to improve quality, speed, and efficiency.
- Lead programming teams, inclusive of global offshore teams responsible for clinical data standards, safety, data governance, data operations, clinical data visualizations, clinical programming, SDTM, disclosures, eSubmissions and Clinical Pharmacology activities.
- Lead continuous improvement initiatives and adoption of modern programming languages/tools (R, Python, cloud analytics, Git/GitHub, automated testing frameworks).
- Oversee the functional strategy and adoption of advanced visual analytics solutions to enable near real-time clinical data exploration, interactive dashboards, and intuitive decision support tools that enhance data quality oversight and accelerate portfolio insights.
- Ensure consistent application of CDISC standards and contribute to the evolution of internal metadata and standard libraries. Act as a strong advocate for global clinical data standards supporting the pursuit and stewardship to drive adherence across study teams.
- Oversee the creation of a centralized CDS data strategy and phased roadmap prioritizing regulatory compliance, business value, FAIR principles and AI-readiness, leveraging a hub-and-spoke model balancing centralized capabilities with embedded domain expertise.
- Partner and collaborate with Clinical Development, Data Management, Biometrics, ARC, Development Systems, and IT to optimize end-to-end data flows from study start-up through submissions and accelerate analytical workflows.
- Owns and manages the budgets and resource plans for assigned areas that typically span a large portfolio of studies / projects and several teams.
- Oversee the delivery of high-quality project/portfolio deliverables.
- Capabilities & Requirements
- Excellent verbal and written communication skills; strong negotiation and interpersonal skills.
- Deep knowledge of the drug development process, regulatory expectations, and industry standards for programming, data structures, and reporting.
- Proven ability to supervise people leaders at multiple levels; ability to delegate, coach, and provide feedback and career development opportunities.
- Proven experience in working wi
Benefits
Additional Information
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 Job Description for Executive Director of Clinical Data Engineering & Analytics (CDEA) Reporting to the Senior Vice President of Clinical Data Science (CDS), the Executive Director Clinical Data Engineering & Analytics (CDEA) provides strategic and functional leadership for the delivery and modernization of programming support through SDTM, including clinical pharmacology, biomarker and Ph1a studies, collaborating closely with the Development Systems and the AI Research Center (ARC). Overseeing Global Clinical Data Standards (GCDS) and CDS's data strategy, this role will also provide functional leadership for the creation of a robust, compliant and modern data foundation that emphasizes data standards, data governance best practices, and AI-readiness-by-design to support our near-term clinical portfolio needs and our long-term AI ambitions. The ideal candidate is a visionary leader with deep clinical trial data expertise, a strong command of regulatory expectations (CDISC, ICH, FDA/EMA), and a passion for transforming clinical & statistical programming through emerging technologies to achieve high-quality results. In addition, the candidate should bring a proven track record of functional leadership and must demonstrate excellence in people leadership, cross-functional collaboration, and organizational development. This is an onsite position located at our global headquarters in Foster City, CA.
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