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 will oversee 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 working through 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, including Clinical Trials Regulation, human biosamples regulations, data privacy regulations and AI regulations. The Associate Director of Data and AI Policy will be 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 of best 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 and track, trace and audit activities

• Lead business enablement data and AI risk evaluation and mitigation projects, driving compliance 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 Offices 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 Offices prowess and accomplishments through targeted communications, celebration of achievements, conferences, and/or external communications

• Represent AstraZeneca externally, promoting AstraZenecas 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

• Bachelors 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 demonstrated experience influencing and communicating with cross-functional leaders

• 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