Director, Development AI Workflow Transformation Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the authority on the end-to-end Development lifecycle workflows, analyzing current processes, identifying pain points, hand-offs, and value drivers across various functions.

• Assess workflows to pinpoint and prioritize high-value opportunities for AI and automation integration.

• Develop a compelling case for the application of AI and automation solutions.

• Reconstruct and redesign workflows to effectively incorporate AI, focusing on optimization, standardization, and simplification of processes.

• Convert business requirements and redesigned workflows into specifications and user stories for the IT team.

• Collaborate with IT on solution design, ensuring that solutions align with intended workflows, while being scalable, sustainable, and adhering to enterprise platforms and standards.

• Establish quality benchmarks for redesigned workflows and verify that implemented solutions yield accurate, high-quality results.

• Guarantee that workflows and AI solutions comply with GxP, 21 CFR Part 11, and data integrity standards.

• Assist in solution testing, user acceptance, and validation processes both pre- and post-deployment.

• Document newly established workflows, train users, and promote adoption throughout the Development team.

• Collaborate with Development, IT, Medical Affairs, CMC, and PPM to align standards, share reusable patterns, and enhance processes continuously.

• Report directly to the Senior Director, Development AI Program Management.

⛳️ Requirements

• A Bachelor’s degree in a scientific, engineering, technology, or related field is required; an advanced degree is preferred.

• Over 10 years of experience in biopharma/life sciences drug development or R&D operations, with extensive hands-on expertise in development lifecycle workflows and process enhancement.

• Proven experience in mapping, redesigning, and optimizing complex cross-functional workflows.

• Practical knowledge of AI/automation capabilities and methods for integrating them into operational workflows.

• Experience in defining requirements for technology solutions.

• Demonstrated ability to translate business needs into precise, actionable requirements and collaborate effectively with IT and technical teams.

• Strong understanding of GxP, 21 CFR Part 11, data integrity, and validation standards for computerized/AI systems.

• Skills in workflow analysis and redesign, requirements definition, stakeholder facilitation, structured problem-solving, and effective written/verbal communication.

• Willingness to travel approximately 10% for cross-functional collaboration as necessary.

• Lean/Six Sigma or business process management experience is highly preferred.

• Lean/Six Sigma (Green/Black Belt), business process management, Agile/Scrum, or similar certifications are preferred; change management certification is a plus.

🏝️ Benefits

• Generous vacation time and public holidays recognized by the organization.

• Volunteer days available.

• Long-term incentives and Employee stock purchase plans or equivalent programs.

• Employee wellbeing benefits offered.

• Fitness reimbursement provided.

• Tuition sponsorship available.

• Professional development plans in place.

• Annual bonuses and equity incentives included.