We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
The Senior Manager of Epidemiology will collaborate cross-functionally to support all epidemiological and evidence generation activities across the company portfolio. This position will support physicians and scientists in multiple functions across the company and report to the CMO.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Responsible for identifying information such as incidence, prevalence, and other epidemiological data to support study proposals and study design.
• Partner with Safety Science and Benefit-Risk Management, and other relevant cross-functional teams to review data in an integrated manner to support benefit-risk assessment throughout the product life cycle.
• Responsible for epidemiologic matters related to product safety and risk management, aggregate data analyses, and post-marketing studies.
• Partner with clinical development, biostatics and data science, safety, medical affairs, and other relevant functions to identify data gaps and support observational studies and evidence generation.
• Support patient exposure calculation, data analyses for aggregate reports (DSUR, PSUR), signal detection and evaluation, and safety review team (SRT) in safety evaluation and assessments.
• Support identification of trends and patterns and interpretation of data in safety assessment and evaluation.
• Proactively identify and resolve safety issues from an epidemiologic perspective in collaboration with other team members.
• Provide timely epidemiologic input into regulatory and risk management reports, labeling, Pharmacovigilance Plans, Safety Monitoring Plans, REMS, and Health Authority requests/Advisory committees.
• Conducts epidemiological research and projects to further understand any potential risks (as needed), as well as to evaluate effectiveness of risk mitigation strategies after implementation.
• Support the team in review of study proposals from internal and external sources, analyses in adverse event reporting system databases (e.g. AERS, WHO), and interpretation and reporting on data analysis
• Conduct critical appraisal and synthesis of relevant epidemiological literature.
• Review relevant statistical analysis plans in collaboration with safety physician, biostatistics, and clinical development.
• Stay informed and involved on the latest regulatory and methodological advances that expand and enhance the utility of epidemiological methods.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Master’s or PhD in Epidemiology with minimum 5-8 years of relevant work experience
• Minimum of 2-3 years of relevant work experience in Pharmaceutical or Biotechnology industry
• Thorough and up-to-date technical knowledge of epidemiology methods and application of epidemiologic approaches to problems in the Pharmaceutical or Biotechnology industry
• Strong data analytic skills, including knowledge of standard statistical software & packages (SAS, R, etc.)
• Excellent verbal and written communication skills with proven ability to clearly articulate insights from findings and develop materials relevant to business leadership.
• Ability to work effectively in multidisciplinary team.
• Strong attention to detail and understanding around leveraging data to answer business problems and hypotheses.
• Strong critical thinking skills to frame problems, guide analysis and draw conclusions from various data sources and analyses.
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.