Director, Immunology Evidence Strategy (Bio Pharmaceuticals Medical

Director, Immunology Evidence Strategy (BioPharmaceuticals Medical)

Introduction to role

At AstraZeneca, we turn ideas into life-changing medicines. Working here means being entrepreneurial, thinking big, and working together to improve the lives of people with serious diseases. The Director role in Medical Evidence Strategy at AstraZeneca is a lead epidemiologist role, driving real-world evidence strategy and delivery from Ph3 projects to post-launch marketed products. Immunology is an exciting growth area in AstraZeneca, and this role will be an integral part of the success of our expanding pipeline and portfolio as part of the cross-functional team.

Accountabilities

The major focus is to describe the unmet need and demonstrate the value of a new medication to a wide range of stakeholders, including clinicians, regulators, payers, and patients, using real-world primary and secondary data sources. As a part of the global Medical Affairs group, medical evidence team members actively provide strategic direction and messages based on real-world evidence to ensure the right patients are managed with optimized treatments at the right time.

Evidence Directors set the tactical RWE plan together with the Evidence Strategy Senior Director and contribute to the annual business strategy planning cycle. They are independent scientific leads for the planning and execution of RW studies, both primary and secondary, and consult on observational methods. Major technical activities include critical appraisal and synthesis of relevant epidemiological literature; design, initiation, management, conduct, analysis, and reporting of epidemiological studies, including observational and interventional studies; and development of medical evidence plans to identify critical knowledge gaps, including support to specialized areas (e.g., biomarker development, disease modelling, & health economics).

Evidence Directors interact with a wide range of internal and external customers to ensure appropriate identification of evidence gaps and communication of results to stakeholders, including providing epidemiological support for responses to questions posed by regulatory authorities. They perform research on secondary data (e.g., electronic healthcare databases) either internally or through collaboration with external research and academic groups. Additionally, they design and conduct primary data collection studies (e.g., non-interventional and interventional) implemented through external service providers. Finally, they ensure that time frames are negotiated appropriately for the completion of tasks, and that the tasks are carried out as agreed and results presented effectively.

Evidence Directors support medical and clinical objectives and also work closely with commercial partners to improve the potential of AstraZeneca’s products and ensure support for appropriate target claims and messages. In this specific role, the successful candidate will be expected to focus on product/s in clinical development and their successful transitions through late-stage clinical development, peri- and post-approval.

Senior staff are also expected to educate colleagues in the principles and practice of epidemiology. Additionally, senior staff will participate in the development of complex medical evidence strategies and drive decisions within a complex matrix drug team environment.

The Evidence Director is a strategic as well as scientific role and involves designing and implementing effective and efficient Medical Evidence strategy for drug and enablement projects at a global level. It requires interaction with diverse scientific, technical, and business experts to ensure scientific quality and timely, effective project delivery while adhering to ethical requirements and responding to business needs.

• The role holder consults with more senior staff as necessary to provide specialist guidance and direction to project teams, senior leaders, and other colleagues to ensure optimal management of high-impact project opportunities and risks. 
• You will work independently in the design, execution, analysis, interpretation, and internal and external communication of epidemiological or Ph4 real-world studies.  This role requires taking a leadership role in a range of activities.
• You will be integrated in a product team contributing to clinical development and commercialization through your expertise in real-world data and methods and disease epidemiology.
• You will deliver highly experienced epidemiology strategy, support, and scientific leadership to project teams and the epidemiology global skills group, at all stages of pharmaceutical development.
• You will manage externally commissioned research projects and keep abreast of epidemiological developments within academia, regulatory, and amo