Director, Study Management AI Lead
Cell Therapy study teams are responsible for delivering a single or several smaller Cell Therapy development programs or leading multiple Cell Therapy studies or single complex/novel studies such as platform, basket, etc. The exact accountabilities will differ depending on the nature of the clinical studies or program, so a high degree of flexibility and autonomy is required.
Director, Study Management AI Lead is a member of Cell Therapy Study Management Leadership Team and is accountable for the leadership, management and continuous improvement of AI solutions used to augment and streamline study management processes.
AI Lead works closely with R&D IT (Information Technology), Global Clinical Solutions, Business Process Management Office (BPMO), internal and external customers and stakeholders to ensure customer needs are met and to enable optimal end-to-end delivery of clinical studies. AI Lead is responsible for the identification, definition and delivery of improvements in end-to-end clinical study delivery in compliance with ICH-GxP and other regulations and aligns with industry direction, standards, and best practices.
AI Lead represents the business interests in strategy discussions and works with appropriate Governance teams to secure long-term business success of their assigned solutions. Reviews and approves identified risks and mitigations, controls and prioritizes business requests, such as those for feature enhancements, ensuring prioritization so resources are spent on value-add activities. Accountable for communication to key stakeholders and the business regarding the system (major incidents, new releases, etc.). AI Lead will contribute to functional, regional and or global initiatives.
Typical Accountabilities:
Accountable for the leadership, management and continuous improvement of AI solutions
Accountable for lifecycle management of all procedural or system documents within the allocated area, and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies.
Defines vision, roadmap and growth opportunities.
Researches and analyses business context, users, and roadmap for assigned solutions
Engages and influences internal and external stakeholders to drive the strategy, development and continuous improvement within the given area.
Ensure customer requirements are understood, critically evaluated, prioritised and addressed within the given area.
Responsible for monitoring performance of the assigned system. Define, track and monitor key performance indicators and inform improvement plans.
Understands the processes, technology and services the study team relies on, their needs and pain points. Uses this knowledge to supply advice and guidance, removes barriers, supplies solutions and finds opportunities for improvement.
Requirements:
Essential
Bachelor of Science (BSc) in a life science or computer science, or equivalent experience
Minimum of 5 years’ experience in clinical research, with at least 2 years in study management
Comprehensive knowledge of the clinical and pharmaceutical drug development process.
Excellent knowledge of ICH-GCP principles
Experience and strength in working and leading matrix teams
Experience working with AI models and solutions
Proven ability in solution focused problem solving and issue management.
Desirable
Higher degree e.g. MSc, PhD
Experience building AI solutions
Experience working with Artificial Intelligence implementation
Date Posted
16-wrz-2025Closing Date
30-wrz-2025AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
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