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Director – Immunology Evidence Strategy – Biopharmaceuticals Medical
Company | AstraZeneca |
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Location | Gaithersburg, MD, USA |
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Salary | $193281.6 – $289922.4 |
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Type | Full-Time |
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Degrees | Master’s, PhD |
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Experience Level | Senior, Expert or higher |
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Requirements
- 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.
Responsibilities
- Describe the unmet need and demonstrate the value of a new medication to stakeholders using real-world primary and secondary data sources
- Set the tactical RWE plan together with the Evidence Strategy Senior Director and contribute to the annual business strategy planning cycle
- Act as independent scientific leads for the planning and execution of RW studies, both primary and secondary
- Consult on observational methods
- Perform critical appraisal and synthesis of relevant epidemiological literature
- Design, initiate, manage, conduct, analyze, and report epidemiological studies, including observational and interventional studies
- Develop medical evidence plans to identify critical knowledge gaps
- Interact with internal and external customers to ensure appropriate identification of evidence gaps and communication of results
- Provide epidemiological support for responses to questions posed by regulatory authorities
- Design and conduct primary data collection studies implemented through external service providers
- Negotiate time frames for task completion and ensure tasks are carried out as agreed
- Support medical and clinical objectives and work closely with commercial partners
- Educate colleagues in the principles and practice of epidemiology
- Participate in the development of complex medical evidence strategies and drive decisions within a complex matrix drug team environment
Preferred Qualifications
No preferred qualifications provided.