A graduate degree (PhD, MD, MS, or MPH) in a relevant field is required.
A doctoral degree holder must have at least 2 years of experience in industry, academia, and/or a regulatory agency.
A master's degree holder must have at least 6 years of experience in a national or local public health agency, regulatory agency, biopharma, and/or the medical device industry, including at least 1 to 2 years of biopharma or medical device industry experience.
Experience and training in public health, pharmacy, health services research, health outcomes research, epidemiology, biostatistics, or another relevant field are required.
Experience with developing and implementing epidemiology research strategies is required.
Expertise in biostatistics, epidemiology and secondary database analyses, including claims and national survey data, is required.
Experience as a member of a product or project team is required.
Experience writing scientific peer-reviewed, academic, and/or public health literature is required.
Familiarity with drug development and Phase 1 through Phase 4 clinical trials is required.
Strong understanding of research methodology and statistics, technical writing, and critical review of published scientific literature is required.
Strong verbal and written communication and presentation skills are required.
Critical thinking and problem-solving skills, with the ability to set priorities and develop strategies or studies to answer complex research questions, are required.
Experience managing multiple complex projects with internal and external stakeholders under short timelines is required.
Ability to analyze and interpret safety data is required.
Understanding of advanced design and analysis techniques for secondary data, including matching, multivariate regression, and meta-analysis, is required.
Ability to conceptualize result presentations, including layouts of tables and figures for analysis plans, is required.
Working knowledge of at least two secondary database types, such as claims, surveys, or electronic medical records, is required.
Working knowledge of standard statistical packages such as SAS and Stata is required.
Ability to contribute to written processes that ensure consistent, high-quality deliverables is required.
Responsibilities
Develop or update safety signal detection and management documents for global developmental and marketed products.
Review or develop epidemiology sections and papers for relevant conferences and peer-reviewed journals.
Develop or support instruments for epidemiological assessment strategies and safety surveillance in coordination with Biostatistics.
Participate in planning and designing, executing, or contributing to observational and interventional studies for assigned products.
Develop epidemiological assessment and safety surveillance plans for assigned projects or studies.
Review epidemiology data supporting risk management plans, risk evaluation and mitigation strategies, and other safety-related documents.
Contribute to the design, implementation, and management of safety studies and clinical trials.
Search and review epidemiological data and safety literature supporting ad hoc or regular safety submissions.
Own epidemiology sections of investigator brochures, risk management plans, aggregate safety reports, including DSUR and PSUR reports, and responses to health agency inquiries.
Perform safety data evaluation and risk assessment for assigned drug products.
Provide or contribute materials for Clinical Safety Team, Data Monitoring Committee, Global Safety Data Monitoring Committee, and Data and Safety Monitoring Board meetings.
Contribute epidemiology input to GST Working Group, Signal Detection, and other Global Drug Safety and Evaluation Center meetings.
Perform other departmental duties as assigned.
Job Description
Develop initial or update safety signal detection and management documents for global developmental and marketed products to support and enhance appropriate signal detection activities and robust safety evaluation
Review and/or develop relevant epidemiology sections and/or papers for relevant conferences and/or peer-reviewed journals as assigned
Develop or support development of instruments for epidemiological assessment strategies and safety surveillance in coordination with Biostatistics
Participate in plan/design, execute or contribute to development of observational studies and interventional studies for assigned global developmental and marketed products
Develop epidemiological assessment and safety surveillance plan for assigned projects or studies
Review epidemiology data in supporting the development of risk management plan/risk evaluation and mitigation strategies (REMS) and other safety related documents
Contribute to the design, implementation, and management of safety studies and clinical trials
Search and review epidemiological data and safety literature in supporting development of Ad hoc or regular safety submissions
Accountable for epidemiology sections of investigator’s brochures, risk management plans, aggregate safety reports (DSUR and PSUR), and responses to health agency’s inquiries for global development and post-marketing products
Perform safety data evaluation and risk assessment for assigned drug products
Provide or contribute to the materials used for Safety meetings including but not limited to the Clinical Safety Team, Data Monitoring Committee, Global Safety Data Monitoring Committee, Data and Safety Monitoring Board (DSMB)
Contribute epidemiology input to GST Working Group meetings, Signal Detection meetings and other Global Drug Safety and Evaluation Center (GDSEC) meetings as assigned
Performs other departmental duties as assigned
Qualifications
Education: Graduate degree (PhD, MD, MS, MPH) in a relevant field is required:
Doctoral degree with at least 2 years of industry experience, academia, and/or regulatory agency
Master’s degree with 6+ years of experience in a national/local public health agency, regulatory agency, biopharma, and/or the medical device industry (including at least 1 to 2 years of biopharma or medical device industry experience)
Professional Experience: Experience and training in public health, pharmacy, health services research, health outcomes research, epidemiology, biostatistics or other relevant fields
Familiarity and experience with the development and implementation of epidemiology research strategies
Expertise in Biostatistics, Epidemiology/ secondary database analyses (e.g., claims, national survey data, etc.), Psychometrics
Demonstrated experience as a member of a product or project team
Experience in scientific writing of peer-reviewed, academic and/or public health literature
Familiarity with Drug Development and Phase 1-4 clinical trials
Knowledge and Skills: Strong understanding of research methodology and statistics, as well as strong technical writing, and strong ability to critically review published scientific literature
Strong verbal and written communication, presentation skills, including experience
Critical thinking and problem-solving skills, ability to set priorities and develop strategies/studies to answer complex research questions
Experience managing multiple projects, often complex in nature and with both internal and external stakeholders under short timelines
Ability to analyze and interpret safety data
Good understanding of advanced design and analysis techniques used in the analysis of secondary data (e.g., matching, multivariate regression, meta-analysis, etc.)
Ability to conceptualize the presentation of results (e.g., develop layout of tables and figures for inclusion in analysis plans)
Working knowledge of 2 or more secondary database types (e.g., claims, surveys, electronic medical records)
Working knowledge/ability to use standard statistical packages (i.e. SAS, STATA, etc)
Ability to contribute to written processes to ensure consistent and quality deliverables
Additional Information
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: