Associate Director, R&D Partnership Legal and Compliance

The R&D Data Office is embarking on a transformative journey to support AstraZeneca's ambition to double the productivity of the R&D drug development pipeline by 2030. This goal will be achieved through the effective use of data and AI to power scientific innovation and accelerate data-driven decisions, ultimately speeding the delivery of medicines to patients. The Data and AI Policy and Governance team is at the forefront of this change, unlocking data and AI use in a responsible manner to enable the business while protecting patient data and meeting regulatory obligations.

The Associate Director of R&D Data & AI Policy (R&D PartnershipLegal and Compliance)will partner with the Director of this function and play a pivotal role by leading projects to shape, implement, and manage regulatory change and reviewscientific researchcontractsembedding data privacy,data transfer, ethical and legal review in the interest of protecting patient data rights.The incumbent will be accountable for the day-to-day management of requests relating to contracts covering topical areas including but not limited to data and AI use in scientific research,while supporting R&D scientists, alliance management and business development teams.This will involve legal, ethical and regulatory reviewincluding verifying the patient informed consent, patient sample use, clinical study protocol, and country data workflow to ensure compliant data transfers. 

Successful candidates will possess the skills and the aptitude to provideconfident advice on contracts, data privacy, and AI, related topics, draft bespoke contract language, create new contract templates to support compliant clinical trial data requests, and contribute to problem-solving solutions to unlock access to valuable research data. 

The Associate Director will be a part of a larger network of legal and compliance professionals that worktogether to enable compliant scientific research including data and AI governance teams, data privacy office, Human Biological Samples (HBS) teams, corporate risk and compliance, procurement, and data sharing operations teams. Thus, building strong relationships with both internal and external partners is essential to implementing a robust contracts, AI, and data privacy strategy using existing policies, business processes, and frameworks. Further, demonstrated experience with stakeholder management, project management, policy development, and knowledge of global laws and regulations, such as the EU AI Act, Clinical Trials Regulation, human biosamples regulations, and data privacy laws (including EU GDPR and UK GDPR)are necessary for success.

Typical Accountabilities

• Contract negotiations and data privacy support: Lead contract negotiations and provide comprehensive support for data privacy and AI-related matters in contracts. Utilize existing contract templates or drafting bespoke language as needed to ensure compliance and address specific requirements.

• Advisory role: Offer expert advice on contracts, AI, and data privacy, particularly concerning the transfer of clinical trial data in and out of AstraZeneca. Ensure that all advice is aligned with regulatory standards and internal policies.

• Management of support requests: Oversee the day-to-day management of incoming support requests related to contract review and data privacy support. Ensure timely and accurate responses to support the business needs.

• Regulatory and legal review: Where applicable, assist with regulatory and legal review of informed consent forms, protocol and other legal documents relevant to a clinical study.

• Project contribution: Actively contribute to projects related to data privacy, contract development, regulatory response developments, and risk and compliance. Provide insights and solutions to enhance project outcomes.

• Maintaining strategic partnerships:Maintain and nurture relationships with strategic internal and externalpartnerships, including the Data Privacy Office, Human Biological Samples team, and external collaboration partners. Foster a collaborative environment to achieve common goals.

• Awareness campaigns and training: Design and implement awareness campaigns and present training sessions on data risks, contracts, regulatory aspects, and data privacy. Educate and empower colleagues to understand and mitigate data-related risks.

• Data risk and compliance consultancy: Provide consultancy services on risk and compliance, helping both the Data Office and business stakeholders understand and apply current policies and best practices. Evaluate new situations and offer guidance on data risks.

• Policy development: Shape, develop, and document policy ways of working, position statements, and standard operating procedures. Incorporate internal requirements and apply external influences to ensure robust policy frameworks.

• Culture of compliance: Develop and promote a culture of data and AI compliance. Collaborate with the Data Office and Data Science and AI community to support data risk management and ensure the compliant use of data and AI.

• Strategic contribution: Actively contribute to the Data and AI Policy and Governance team strategy, goals, and roadmap. Align individual efforts with the broader organizational objectives.

• Trusted business partner: Act as a trusted business partner by using creativity to solve challenges, influence to remove barriers, and voice to escalate risks and situations involving contracts, regulatory issues, or data privacy.

• Team culture: Contribute to the R&D Data Office’s innovative and inclusive culture. Bring your authentic self, engage in community activities, celebrate diversity, take risks, and embrace failures as learning opportunities.

• Evangelism and representation: Promote the R&D Data Office’s achievements through targeted communications, conferences, and external engagements. Represent AstraZeneca externally, showcasing the company's commitment to responsible data and AI use.

Education, Qualifications, Skills and Experience

• Demonstrated experience working cross functionally in leading contract and data privacy supportimplementation projects in the life sciences or pharma industry.

• Bachelor’s degree from an accredited university in a relevant legal field.

• Being an admitted lawyer or solicitor in your country of residence.

• Solid experience in contracts, including drafting, negotiation and supporting it as far as it relates to data transfers in and out of the company.

• Solid experience in data privacy globally, especially solid experience with GDPR compliance.

• Solid experience and understanding of Intellectual Property Rights and the ability to negotiate these terms in a contract.

• Requires a confident approach to providing advice internally to colleagues and stakeholders.

• Working knowledge of the EU AI Act and other relevant AI legislation.

• Operational understanding of legal & ethical compliance frameworks, data risks, contract an data privacy risk.

• 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