Director, Development AI Workflow Transformation Lead

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $198.2k - $244.9k / year

⏰ Full Time

🟠 Senior

🤖 Artificial Intelligence

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Ultragenyx

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2010

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Ultragenyx is a biopharmaceutical company dedicated to transforming the lives of individuals with rare and ultrarare genetic diseases. The company focuses on developing and delivering treatments for conditions where no current therapies exist, utilizing a variety of drug modalities tailored to each disease. Ultragenyx boasts a robust and diverse clinical pipeline, with therapies in development for genetic diseases such as Wilson Disease, osteogenesis imperfecta, and Angelman Syndrome. With a passionate team and a commitment to patient advocacy, Ultragenyx aims to lead the way in pioneering therapies that significantly impact rare disease communities.

📋 Description

• Serve as the Development authority on end-to-end Development lifecycle workflows, mapping current-state processes, pain points, hand-offs, and value drivers across functions • Evaluate workflows to identify and qualify high-value opportunities for AI and automation • Build the case for where and how AI and automation solutions should be applied • Re-engineer and redesign workflows to embed AI effectively, optimizing, standardizing, and simplifying processes • Translate business needs and redesigned workflows into requirements and user stories for IT • Partner with IT on solution design and ensure solutions fit intended workflows, are scalable, sustainable, and use enterprise platforms and standards • Define quality criteria for redesigned workflows and validate deployed solutions produce accurate, high-quality outputs • Ensure workflows and AI solutions meet GxP, 21 CFR Part 11, and data-integrity requirements • Support solution testing, user acceptance, and validation before and after deployment • Document new workflows, train users, and drive adoption across Development • Collaborate with Development, IT, Medical Affairs, CMC, and PPM to align standards, share reusable patterns, and continuously improve processes • Report to the Senior Director, Development AI Program Management

🎯 Requirements

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

🏖️ Benefits

• Generous vacation time and public holidays observed by the company • Volunteer days • Long term incentive and Employee stock purchase plans or equivalent offerings • Employee wellbeing benefits • Fitness reimbursement • Tuition sponsoring • Professional development plans • Annual bonus and equity incentives