Director, AI Workflow Transformation Lead

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The Director, AI Workflow Transformation Lead is Development’s subject-matter expert on our drug-development lifecycle workflows, responsible for identifying where AI and automation can create the greatest value and redesigning processes to embed those solutions effectively. Reporting to the Senior Director, Development AI Program Management, this role translates deep operational and workflow knowledge into clear opportunities and requirements, partnering with IT to ensure solutions are scalable, compliant, and aligned to business needs. They lead process redesign end-to-end—mapping current-state workflows, defining future-state, and re-engineering how work gets done so AI is adopted, not just deployed. This is a hands-on transformation leadership role at the intersection of Development expertise, process excellence, and enterprise AI.

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Workflow expertise. Serve as the Development authority on end-to-end Development lifecycle workflows including mapping our current-state processes, pain points, hand-offs, and value drivers across functions.
• AI opportunity identification. Systematically evaluate workflows to identify and qualify high-value opportunities for AI and automation, building the case for where and how solutions should be applied.
• Process redesign. Re-engineer and redesign workflows to embed AI effectively, optimizing, standardizing, and simplifying processes so solutions deliver real efficiency and quality gains.
• Business-to-technology translation. Translate business needs and redesigned workflows into clear, accurate requirements and user stories that IT can build against, ensuring requirements accuracy throughout.
• Solution design partnership. Partner with IT to shape solution design, confirm solutions fit the intended workflow, and ensure they are scalable, sustainable, and built on enterprise platforms and standards.
• Quality & value of output. Define what "good" looks like for each redesigned workflow and validate that deployed solutions produce accurate, high-quality outputs that realize the intended value.
• Compliance by design. Ensure redesigned workflows and embedded AI solutions meet GxP, 21 CFR Part 11, and data-integrity requirements, with human accountability and controls built in from the start.
• Testing & validation support. Support solution testing, user acceptance, and validation to confirm workflows perform as designed before and after deployment.
• Change enablement. Partner with delivery and change teams to document new workflows, train users, and drive adoption so redesigned processes stick and scale across Development.
• Cross-functional collaboration. Engage Development, IT, and partner functions (Medical Affairs, CMC, PPM) to align on workflow standards, share reusable patterns, and continuously improve processes.

Requirements:

• Education. Bachelor's degree in a scientific, engineering, technology, or related discipline required; advanced degree preferred.
• Experience. 10+ years in biopharma/life sciences drug development or R&D operations, with deep hands-on knowledge of development lifecycle workflows and process improvement.
• Process & workflow expertise. Demonstrated experience mapping, redesigning, and optimizing complex cross-functional workflows; Lean/Six Sigma or business-process management experience strongly preferred.
• AI & digital fluency. Practical understanding of AI/automation capabilities and how to embed them into operational workflows; experience defining requirements for technology solutions.
• Business-to-technology translation. Proven ability to convert business needs into clear, accurate requirements and to partner effectively with IT and technical teams.
• Regulatory & compliance. Strong working knowledge of GxP, 21 CFR Part 11, data integrity, and validation requirements for computerized/AI systems.
• Certifications (preferred). Lean/Six Sigma (Green/Black Belt), business-process management, Agile/Scrum, or equivalent; change-management certification a plus.
• Skills. Workflow analysis and redesign, requirements definition, stakeholder facilitation, structured problem-solving, and clear written/verbal communication.
• Travel. Ability to travel up to ~10% for cross-functional collaboration as needed.