Director, Epidemiology - Respiratory & Immunology (R&I)
AstraZeneca

Gaithersburg, Maryland

Posted in Pharmaceuticals
28 days ago



Job Description

At AstraZeneca we win through science, it's at the heart of our every success. That science is only possible when we all work together - we'll always make sure you're clear about how your role is connected to our wider mission to really show what science can do.

At AstraZeneca we're relentlessly curious about science, and pursue our work with passion. We believe that when we follow the science we can make game-changing discoveries that can transform the lives of patients around the world.

Summary:

BioPharmaceuticals Medical (BPM) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AZ therapies and support our internal stakeholders with medical insight and expertise. BPM provides medical leadership with market participation and connectivity while also impacting the life cycle planning and execution of all our products. aims to lead AstraZeneca in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do.

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. Within their activities, epidemiologists 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 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.

Typical Accountabilities:

The 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. 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 Director, Epidemiology works 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, including delivery of experienced epidemiology strategy, support, and scientific leadership to project teams and the epidemiology global skills group, at all stages of pharmaceutical development.

The Director, Epidemiology manages externally commissioned research projects, which includes establishing, maintaining, and expanding relationships to partner effectively with external experts and research groups to negotiate time frames, provide recommendations on resource requirements, and ensure delivery of the tasks as agreed.

The Director, Epidemiology promotes good epidemiological practice and represents the company's position when interacting with external experts, collaborative groups, and contract research organizations; and will keep abreast of epidemiological developments within academia, regulatory, and among key opinion leaders.

Education, Qualifications, Skills and Experience

Essential:

  • Ph.D. or equivalent in epidemiology or related health science field and experience in the health care environment. Alternatively, an MSc or MPH with substantial experience in the health care environment or equivalent.
  • ≥3 years experience in the pharmaceutical industry or in closely related academic epidemiological research
  • 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 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
  • 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
  • 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
  • Proactive and able to work independently
  • Proven team-working skills


Desirable:
  • Ability to apply advanced epidemiological theory and techniques throughout the product life cycle
  • Good therapeutic and disease area knowledge and knowledge of drug development and life cycle management
  • Experience managing complex medical evidence programs, 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 leaders
  • 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 behaviors 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
  • Experience working in immunology


#immunology_build_20




Share this job with the community

Click a community link below, and then social share the Director, Epidemiology - Respiratory & Immunology (R&I) job.


African American Job Search Logo
Asian Job Search Logo
Disabled Job Seekers Logo
Hispanic Job Exchange Logo
LGBT Job Search Logo
Seniors to Work Logo
US Diversity Job Search Logo
Veteran Job Center Logo