Executive Director of Clinical Data Engineering & Analytics (CDEA)

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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.

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 with global teams and navigating through time zone challenges to remain committed to achieving on-time delivery.

• Ability to provide Statistical Programmers with structured frameworks for decision making and guide consistent and high-quality execution.

• Excellent judgment and problem-solving skills in complex situations; ability to prioritize the most important aspects of an issue and execute creative thinking to promptly resolve

• Ability to lead strategic initiatives and innovations within Statistical Programming and implement infrastructure or process improvements that enhance compliance, efficiency and quality.

• Ability to integrate planning efforts with cross functional partners to ensure organizational effectiveness; ability to influence decision making and negotiate feasible timelines and/or requirements

• Ability to advise senior leadership on programming strategy, functional needs, and technology modernization.

• Serve as a visible change leader (Change Champion) who guides teams through complex transformation, fostering a culture of continuous improvement, innovation, and operational excellence.

Experience Requirements

• Bachelor’s degree or higher in Biostatistics, Computer Science, or related field with 16+ years of relevant industry experience in programming supporting biopharmaceutical data.

• Extensive experience with SAS®, R or Python, and industry standard programming tools.

• Proven track record applying AI, machine learning or advanced automation in data science or statistical programming environments.

• Hands-on experience with current AI-assisted integrated development environments (IDEs) (e.g. Cursor, Claude, Kiro, etc).

• Demonstrated ability to lead change management activities to champion modern technology adoption.

• Demonstrated leadership in driving adoption of standards.

• Participation in CDISC, PHUSE, ASA, R Consortium, or similar external working groups.

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