Executive Director, Standards, Automation and Specialist Programming

Executive Director, Standards, Automation and Specialist Programming

Cambridge / Boston / Gaithersburg / Warsaw

About Astra Zeneca:

AstraZeneca is a global, science-led biopharmaceutical company and our innovative medicines are used by millions of patients worldwide. Here we ensure everyone can reach their full potential, perform at their best and make a valued contribution to the enterprise. 

Development Operations brings together all the skills groups to drive critical operational activities for early and late stage medicines development.

We have deep and specialist expertise in study and site management, data management, technical systems and processes, and in working with CROs and partner organisations to ensure the fast, efficient, ethical and quality delivery of our clinical trials in countries around the world.

We are nearly 2,500 people operating in more than 45 countries across the globe - partnering with the early and late TAs to meet the demands of extensive clinical trial programmes involving many thousands of patients.

Executive Director, Standards, Automation and Specialist Programming

Are you ready to lead the charge in transforming clinical data standards and automation across R&D? As the Head of Standards, Automation and Specialist Programming, you'll be at the forefront of innovation, driving enterprise-wide strategies and collaborating with senior stakeholders to revolutionize data management. This pivotal role demands a visionary leader who can inspire change and deliver exceptional customer satisfaction through transparency and communication. Join us in shaping the future of clinical data standards and automation!

Accountabilities:
• Lead AZ-wide Clinical Data Standards, automation, and Specialist Programming.
• Oversee a robust governance framework for enterprise-wide clinical data standards.
• Develop and maintain end-to-end data standards across Oncology & BioPharmaceuticals portfolios.
• Influence consistent approaches to data infrastructure across the enterprise.
• Lead de-identification, data visualization, and safety reporting groups.
• Ensure functional delivery of safety surveillance and periodic reporting.
• Champion safety data standards integration through expert information management.
• Develop strategies to address challenges in AZ drug development.
• Foster collaborative partnerships for technical alignment.
• Lead global Automation group for cross-functional automation solutions.
• Recruit and develop top talent for cutting-edge methods and tools.

Essential Skills/Experience:

• BSc in mathematics, statistics, engineering, computer science, or life or social sciences (postgraduate degree preferred).
• Extensive statistical programming or related experience in Pharmaceuticals or closely related field.
• Relevant SAS programming knowledge and experience to a proficient level.
• Expert knowledge of clinical data standards (e.g., CDASH, SDTM, ADaM) and global NDA/BLA regulatory submission requirements.
• Experience defining and delivering end-to-end clinical data standards, including standards governance mechanisms.
• Experience leading business units performing end-to-end software and system development and lifecycle management, in support of clinical drug development.
• Strategic thinking to translate strategy to operational execution.
• Strong leadership capabilities including ability to drive results and collaborate, communicate, network and influence effectively across a wide range of internal and external stakeholders at varying levels of seniority.
• Track-record of innovation delivering improved business outcomes.
• Demonstrated knowledge of regulatory requirements supporting clinical trials and submissions.
• Willingness to champion global change across functions and actively advocate and implement more effective methods.

Desirable Skills/Experience:

• Understanding of programming languages (e.g., SAS, R, Java, Groovy, Spotfire, C/C++, VBA/VBS, .NET, Python, Pearl).
• Extensive experience in end-to-end software tool/solution development and lifecycle management.
• Significant validated experience designing and implementing business processes.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility.

At AstraZeneca, we are driven by our passion for science and our commitment to making a difference. Our innovative approach combines data and technology with scientific breakthroughs to tackle some of the world's most complex diseases. We foster an inclusive environment where curiosity thrives, empowering our teams to explore new possibilities without fear of failure. With a focus on lifelong learning and collaboration, we unite diverse expertise from academia, biotechs, and industry to create impactful solutions. Join us as we push the boundaries of science to deliver life-changing medicines.

Ready to make an impact? Apply now to join our team!

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 authorization and employment eligibility verification requirements.