Director, Immunology Evidence Strategy (BioPharmaceuticals 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 among key opinion leaders.
• You will establish, maintain and expand relationships and work effectively with external experts and research groups.
• You will negotiate time frames, provide recommendations on resource requirements, and ensure delivery of the tasks as agreed.
• You will promote good epidemiological practice and represent the company’s position when interacting with external experts, collaborative groups, or contract research organizations.

Essential Skills/Experience

• You will have substantial experience in pharmacoepidemiology and/or disease epidemiology. 
• Ph.D. or equivalent in epidemiology or related health science field and substantial experience in the health care environment.  Alternatively, an MSc or MPH with consolidated experience in the health care environment.
• Experience in the pharmaceutical industry or in closely related academic epidemiological research.
• Experience managing complex medical evidence plans.
• Able to provide critical appraisal to study designs and published studies.
• Sustained productivity in epidemiological research as manifested by successful design, execution, and publication of original epidemiological research relevant to drug discovery and development (e.g., drug safety) or commercialization, in a peer-reviewed journal.
• Sustained record of epidemiological productivity at a strategic as well as an operational level.
• In depth experience in utilizing secondary real-world data.
• Recognition by the external scientific communities as an expert in the application of epidemiology to areas relevant to drug development and commercialization
• Able to effectively engage and consult with recognized key external scientific experts.

The annual base pay for this position ranges from $193,281.60 - 289,922.40 USD. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered include a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Why AstraZeneca?

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. Join us in our unique and ambitious world.

Embrace the opportunity to shape the future of healthcare. Be part of changing the practice of medicine forever. A place to be at the forefront; proactive, innovative, and brave, we don't stop. It means we dare to do the big studies in the real world, applying primary and secondary data, leading the field in evidence generation and external scientific engagement. We have an opportunity to see how the compelling medical evidence we generated and communicated influences the basis of future healthcare.

Ready to make a difference? Apply now!

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.