At AstraZeneca, we are united by a common purpose – to push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do; our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide and by leading breakthrough science that promises to transform the treatment of disease.

Our purpose is bold and so is our approach. Becoming a more agile and innovative company means creating a vibrant, dynamic culture where we celebrate entrepreneurial thinking and motivated by a sense of urgency. We are courageous, we seek risks and learn from both success and failure. We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of a great place to work; an environment that energizes and empowers each of us to achieve our goal to develop and deliver needed medicines.

Position Title: Associate Director, RWD/RWE

Position Type: Secondment/Domestic Assignment, Full-Time

Location: The successful candidate will work/reside in Canada (Mississauga), Cambridge, Warsaw, Sweden, Gaithersberg

Career Level: F

You will work in partnership with Global Development Operations and Global TA leads to enable expedited, data driven, predictive delivery for early feasibility and planning, protocol optimization, site identification, and patient recruitment at TA/Indication/Program and study level, for AZ early and late stage clinical trial portfolio. In addition, this role will provide RWD-related ad-hoc analytical support to clinical teams.

You have expertise in coding and terminology, protocol interpretation and query generation in RWD/EHR data and in-depth knowledge of Global Feasibility Site Intelligence practices, providing better alignment to functions needs and enables input to continuous evolution of real-world data and tools.

You engage with key internal stakeholders including but not limited to Global Feasibility and Site Intelligence Group, TA leads (DCD/ADCD, Study Physician), Global, Regional and Country operational representatives (BSPD, and SMM Reg Directors),  to drive the usage and scale of federated EHR platforms in supporting trial decisions across AstraZeneca. This role will also collaborate with Health Informatics team and Data Science & Artificial Intelligence team, and external Federated EHR vendors.

Your responsibilities will include:

• Drive continued capability build of RWE/RWD for clinical trials implementation of EHR enabled trial model scaleup. This includes but not limited to providing RWE/RWD-related analytics and feasibility support to AstraZeneca clinical programs and trials, evaluation of new data sources and tools, providing data-driven protocol optimization, site selection and patient recruitment analysis and support communications and trainings required by the implementation of a hybrid centralized-decentralized model
  • Experience in data transformations and creating an analytical dataset (if required) or directly working in the Federated EHR platforms or RWD platforms
  • Analyze relevant patient cohorts and determine study feasibility
  • Perform RWD/RWE analysis for protocol optimization, site selection and patient recruitment
  • Support evaluation of new RWD/RWE providers or datasets and develop the recommendation for clinical program and trial use
  • Perform quality checks
  • Provide data analysis and interpretation to support rapid and objective decision making
  • Act as global Subject Matter Expert for EHR data, tools and process
  • Manage process using FED EHR platform and new study design and planning digital platform (Merlin)
  • Engage key stakeholder in business involved in protocol optimization and site selection, Global Feasibility and Site Intelligence group, TA and CPT roles (e.g. DCD/ADCD, physician leads), Health Informatics SMM region and country roles, global study team
  • Create and deliver training materials to new users of FED EHR platform
  • Work with new InSite and TriNetX users to illustrate multiple querying methods, business processes, etc.
  • Act as advisor for external CRO/ARO delivery of protocol development and site identification

• Deliver agreed EHR KPIs and communicate results and impact via performance dashboards for Development Operations. Build and iterate operational process, as new features become available
  • Maintain dashboard for KPIs
  • Present live demos of capabilities
  • Communicate value, use cases & nuances relevant to stakeholder and cross functional teams

• Maintains awareness of marketplace activities, policies, trends, technology and information affecting the business and organization to support continued improvement of clinical EHR efforts

Your qualifications and experiences include:

• Bachelor or advanced degree in biomedical science or related Expertise in medical coding & terminology such as ICD-10, CPT, etc.
• TA knowledge - Experience in AZ core Therapeutic Areas/Indication
• Understand how to interpret clinical protocol
• Experience from Drug Development and Feasibility in the pharmaceutical industry
• Proven experience in data analysis, data interpretation to inform decision making
• Proven experience in managing, influencing, building and maintaining relationships and achieving results with senior stakeholders in conflicting priority environment
• Ability to manage multiple studies with competing deadlines, agility to work with changing business needs
• Ability to solve unstructured problems and build processes independently, a critical and strategic thinking mindset
• Proven experience in project and budget management
• Proven experience working with Global teams

Your may have the following qualifications or experiences:

• Degree in Health Informatics
• New product development experience within the pharmaceutical industry
• Proven project/program management or other complex/cross-border management experience
• Proven experience working with partners, CROs/AROs
• Proven experience in the development of business cases
• Understand clinical development process where FED EHR can be incorporated

Date Posted

Closing Date

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.