Associate Director, Epidemiology/Director, Epidemiology – Gaithersburg, MD
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As an Associate Director, Epidemiology (Grade E)/Director, Epidemiology (Grade F) in Gaithersburg, MD you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. GPPS (Global Product and Portfolio Strategy) bridges science and commercial, integrating corporate, portfolio, therapy areas and product strategies, providing strategic direction from early-stage research through to commercialization.
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 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. 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 is 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
The Director, Epidemiology is a high-level, strategic and scientific role that involves developing, coordinating, and executing cutting-edge, effective, and efficient epidemiology strategy for drug and enablement projects at a global level. The incumbent has deep knowledge and extensive experience and provides essential specialist guidance and direction to project teams, senior leaders, and other colleagues to ensure optimal management of high-impact project opportunities and risks. The role holder leads development of consensus among diverse scientific, technical, and business experts (often at the global level) so as to ensure scientific quality and timely, cost-effective project delivery while adhering to ethical requirements and responding to business needs.
The Director, Epidemiology will work independently and guide more junior staff 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, e.g.:
- Deliver highly experienced strategic input, epidemiological support, and leadership to project teams and the Medical Evidence and Observational Research Group during all stages of pharmaceutical development to maximize the market potential of AstraZeneca products, manage risks, and optimise epidemiological processes and methods.
- Deliver research (e.g., observational and interventional) to enhance the effectiveness of epidemiology contributions to world-wide regulatory submissions and the drug research process including discovery, development and commercialisation.
- Effectively negotiate with and influence senior leadership and a wide range of project teams.
- Provide innovative thinking regarding the design of clinical and epidemiological programmes, including non-interventional studies and interventional studies such as pragmatic trials.
- Set standards for utilization of epidemiology, provide methodological leadership and input to epidemiological strategies.
- Identify and validate external data sources for the oncology real world evidence data strategy.
- Develop relationships with international opinion leaders and collaborative groups to enhance the standing of the Medical Evidence and Observational Research Group and epidemiologists in the external scientific/academic community.
- Provide strategic guidance to the Medical Evidence and Observational Research Group, Global Medical Affairs, and to the company in a specific epidemiological area of expertise, and typically, in a specific therapy area.
The Associate 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 so as to ensure scientific quality and timely, effective project delivery while adhering to ethical requirements and responding to business needs. The incumbent has substantial experience in epidemiological research in drug development or in a closely related academic research area. 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.
The Associate Director, Epidemiology will 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, e.g.:
- Deliver highly experienced 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.
- 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.
- Keep abreast of epidemiological developments within academia, regulatory, and among key opinion leaders.
- For the Director, Epidemiology - Ph.D. or equivalent in epidemiology or related health science field and a minimum of 5 years of experience in the health care environment. Alternatively, an MSc or MPH with more than 10 years of experience in the health care environment
- For the Associate Director, Epidemiology - Ph.D. or equivalent in epidemiology or related health science field and a minimum of 3 years of experience in the health care environment. Alternatively, an MSc or MPH with more than 5 years of experience in the health care environment.
- Experience in the pharmaceutical industry
- Experience managing complex medical 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 (oncology) knowledge and knowledge of drug development and life cycle management
- Experience managing complex medical evidence programmes, including interventional studies such as pragmatic trials
- Ability to work effectively with External Experts, Collaborative Groups and Contract Research Organizations
- Ability to present advanced epidemiological topics at Professional and Scientific meetings
- Ability to incorporate novel epidemiological techniques into projects
- High degree of conceptual thinking skills
- Excellent understanding of overall business strategy and its link to the various disease areas
- Familiarity with relevant regional and international regulatory requirements
- Ability to make complex judgments, develop innovative solutions, and apply comprehensive cross-functional and industry understanding to individual projects and programs
- Ability to access external resources as necessary, including specialist expertise
- Ability to effectively represent the company to external stakeholders, including regulatory authorities and key scientific opinion leaders4
- Proactive and able to work independently
- Proven team-working skills
- Able to respond to changes in the internal and external environment by adjusting plans or developing new ways of working
- Excellent communication skills and cultural sensitivity
- Ability to influence – through effective communication, respectful challenge, and persuasion rather than dictate – the beliefs, opinions and behaviours of key customers and others at a senior level across the business (including Discovery, Development and Commercial functions).
- Ability to effectively engage with a wide variety of technical and business experts
- Strategic direction
Next Steps – Apply today!
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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.