Associate Director, R&D Data and AI Policy
The R&D Data Office is embarking on a bold transformation to support AZ ambitions to double the productivity of the R&D drug development pipeline by 2030; empowered through effective use of data and AI to power scientific innovation and accelerate data driven decisions speeding the delivery of medicines for patients. The Data and AI Policy and Governance team stands at the forefront of this change; unlocking data and AI use in a responsible way to enable the business while at the same time protecting patient data and meeting our regulatory obligations. The Associate Director of Data and AI Policy will play a key role in this mission leading projects to shape, implement, and manage data policies balancing business benefit and risk enabling responsible use of data and AI.
The Associate Director of Data and AI Policy willoversee our data and AI risk framework; working closely with data customers, data office, data privacy, clinical ICF and HBS process owners, legal, information security, IT, and corporate risk and compliance offices; to evaluate business needs and establish responsible ways of workingthrough risk balance and mitigation.They will be required to employ a range of skills including policy expertise, project management, stakeholder management, and knowledge of global regulations,includingClinical Trials Regulation, human biosamples regulations, data privacy regulationsand AI regulations. The Associate Director of Data and AI Policy willbe accountable for the strategy and execution of data and AI risk framework, leading it in a way that builds strong relations with and effective business processes for internal and external partners and stakeholders, based on excellent insight of customer needs, ethical, legal, and security considerations, and driving toward the establishment ofbest practice for data and AI policy.
Typical Accountabilities
Accountable for overseeing the data and AI risk framework, establishing regular reporting of major & critical data risks
Lead the successful implementation of the data risk benefit package in line with the established R&D data risk appetite
Oversee the day-to-day management of the data risk registers in the Veeva Quality Vault (VQV)
Oversee the day-to-day management of compliance monitoring andtrack, trace and audit activities
Lead business enablement data and AI risk evaluation and mitigation projects, drivingcompliance colleagues towards an effective understanding of the business need and collaborative assessment and design of best practice and policy
Provide expert risk and compliance consultancy services, helping both Data Office and business stakeholders to understand and apply current policies and best practices and/or evaluate new situations
Partner with R&D process and/or technology transformation programs to provide oversight ensuring compliance checklist is achieved and Compliance by Design monitoring is embedded within the program
Manage the shaping, development, and documentation of policy ways of working position statements and standard operating procedures, incorporating internal requirements and applying external influences
Maintain relationships with key stakeholders and close awareness of corporate initiatives, industry standards, and regulations
Develop a culture of data and AI compliance, collaborating with other members of the Data Office and Data Science and AI community to support data risk management and ensure compliant use of data and AI
Actively contribute to the Data and AI Policy and Governance team strategy, goals, and roadmap
Act as a trusted business partner; using creativity to solve for challenges; using influence to remove barriers; and using voice to escalate risks and issues
Actively contribute to the R&D Data Office’s fun and innovative culture, bring your authentic self, take time for community, celebrate the diversity of thought and identity, take risks, and accept failures
Contribute to the evangelism of R&D Data Office’s prowess and accomplishments through targeted communications, celebration of achievements, conferences, and/or external communications
Represent AstraZeneca externally, promoting AstraZeneca’s position and value proposition in responsible data and AI use, and be the exemplary thought leader within AstraZeneca in this space.
Lead / mentor junior staff as required
Essential Requirements:
Demonstrated 8+ years of experience working cross functionally in leading data strategy and/or compliance implementation projects in the life sciences or pharma industry
Bachelor’s degree from an accredited university in a relevant scientific, legal, compliance, technical, and/or business field
Solid experience in risk management processes and hands-on implementation processes
Operational understanding of legal & ethical compliance frameworks, data repositories, data management principles, and analytic tools
Excellent communication skills and ability to build strong relationships. Ability to liaise with people at all levels.
Requires the energy, experience, and motivation to work across global & functional boundaries
Strong project or programme management skills
Excellent organisational skills, and ability to juggle different projects/priorities and deliver high quality outcomes under pressure
Travel – willingness and ability to travel domestically & internationally.
Resilience – ability to overcome and motivate others in the face of a changing environment
Desirable Requirements
Highly collaborative with demonstratedexperience influencing and communicating with cross-functionalleaders
Energized by developing a culture of compliance and continuous learning environment
Proven ability to tackle the unknown with confidence
Energized by working with talented and diverse teams toward a common goal, often translating through communication gaps
Experience of achieving tangible and acknowledged value in a similar position and scale of challenge and opportunity
Experience working with IT partners in the implementation of data related projects
Ability to learn new tools and technologies
Change Management track record
Location: Barcelona