AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
Associate Director/Director, Epidemiology
AstraZeneca is a science-led, global biopharmaceutical company, with a focused portfolio in core therapies. We are committed to improving the health and lives of people across the globe, through our broad research and development platform, and a growing late-stage pipeline. Working in over 100 countries, we have strength in emerging markets, and our medicines are used by millions of patients and clinicians worldwide. At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.
Epidemiologists at AstraZeneca support drug discovery and development as well as commercialization of pharmaceuticals. Major 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 and payer evidence plans to fill critical knowledge gaps, including support to specialized areas (e.g., biomarker development, disease modelling, health economics).
Epidemiologists interact with internal and external customers to ensure appropriate 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) through external service providers.
Epidemiologists support safety and clinical objectives and also work closely with commercial partners to maximize the potential of AstraZeneca’s products and ensure support for appropriate target claims and messages. Moreover, epidemiologists work close with the payer team to identify, build and close evidence gaps relevant to unlock and maintain the access to the drugs. Finally, they ensure that timeframes are negotiated appropriately for the completion of tasks, and that the tasks are carried out as agreed and results presented effectively.
Progression in the Epidemiology career ladder at AstraZeneca requires an increasingly sophisticated understanding of drug discovery and development, clinical research and epidemiological methods, data sources, informatics tools and techniques, disease pathophysiology, risk management, the regulatory environment in the relevant therapeutic area, and factors that influence successful product differentiation and commercialization. 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.
Main Duties and Responsibilities Overview
The Associate Director/Director, Epidemiology is a strategic as well as scientific role and involves designing and executing effective and efficient epidemiology strategy for drug and enablement projects, sometimes 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.
- Provide specialist guidance and direction to project teams, senior leaders, and is to collaborate with senior colleagues and peers to ensure optimal management of high-impact project opportunities and risks
- Work independently in the design, execution, analysis, interpretation, and internal and external communication of specific epidemiological studies. This role requires taking a leadership role in a range of activities
- Deliver epidemiology strategy, support, and scientific leadership to project teams and the epidemiology global skills group, at all stages of pharmaceutical development
- Manage externally commissioned research projects and keep abreast of epidemiological developments within academia, regulatory, health policy providers, reimbursement authorities and key opinion leaders
- Establish, maintain and expand relationships and work effectively with external experts and research groups
- Negotiate time frames, provide recommendations on resource requirements, and ensure delivery of the tasks as agreed
- Promote good epidemiological practice and represent the company’s position when interacting with external experts, collaborative groups, or contract research organizations.
- Experience in design of studies that support conditional drugs’ approvals (regulatory/reimbursement)
- Experience in utilizing real world and other data to support value-based outcomes collaborations with health care providers and reimbursement authorities
- Experience in supporting Global Reimbursement Dossiers and Global Value Packs and utilizing Real World Data to support Payer needs
- Substantial experience in epidemiological research in drug development or in a closely related academic research area
- Ph.D. or equivalent in epidemiology or related health science field and substantial experience in the health care environment and/or outcome researches. Alternatively, an MSc or MPH with consolidated experience in the health care environment and/or outcome researches
- Experience in the pharmaceutical industry or in closely related academic epidemiological research
- Experience managing complex medical and payer evidence plans
- Sustained productivity in epidemiological research as manifest by successful design, execution, and publication of original epidemiological research relevant to drug discovery and development (e.g., drug safety) or commercialization in peer-reviewed journal
- Experience in utilizing secondary data and also conducting primary data collection studies
- Emerging recognition by the external scientific communities as an expert in the application of epidemiology to areas relevant to drug development and commercialization
- Sustained record of epidemiological productivity at a strategic as well as an operational level
- Able to effectively engage and consult with recognized key external scientific experts.
- Able to provide critical appraisal to study designs and published studies
- Excellent knowledge in epidemiological methodology and ability to apply it within the pharmaceutical industry at an international level
- Ability to apply advanced epidemiological theory and techniques throughout the product life cycle
- Good therapeutic and disease area knowledge (Oncology, CVRM, Respiratory) and knowledge of drug development and life cycle management
- Experience managing complex medical evidence programmes, including interventional studies such as pragmatic trials or/and PASS
- Experience in Health Economics and Outcome Researches
- Ability to work effectively with External Experts, Collaborative Groups and Contract Research Organisations
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.