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Director of Health Economic Outcomes Research Job Summary:
- To develop health economics and outcomes research strategy and design, conduct, and report on high quality studies for Purdue Pharma L.P.’s rapidly diversifying pipeline and currently marketed products including pipeline developmental compounds in diverse therapeutic areas such as: non-opioid, sleep related, oncology and early stage psoriasis.
- To develop and submit scientific publications, FDA reports, payer presentations, and other documents for epidemiology, health outcomes, and health economic studies within the Medical Affairs Strategic Research (MASR) Dept.
- To contribute to strategic plans for marketed and development products within Purdue’s portfolio.
- To communicate effectively across departments and serve as a ‘bridge’ between development and marketed products.
- To represent MASR and Purdue on various internal and external groups, including cross-departmental collaborations, interactions with regulatory authorities, professional society initiatives, cross-industry collaborations, interactions with non-governmental organizations, and others.
The candidate will collaborate on teams with colleagues in MASR, other departments within the company, and key medical and scientific opinion leaders to develop, execute, and report on health economics, outcomes research, and epidemiologic studies including:
- Population characterization and treatment utilization studies, in support of both business development assessments and clinical trial planning
- Post-marketing commitments to FDA to evaluate safety and treatment patterns for marketed products
- Health economic studies for new and existing products
- Epidemiologic studies to assess the background rates of potential adverse events among specific patient groups
- Studies to support the benefit-risk assessment of products, including among special populations
- Studies to validate PROs and other outcomes for use in studies targeted at regulators, payers, and healthcare providers
- Other observational studies to support company priorities
In addition, the candidate will draft, submit, and revise publications for peer-reviewed medical and health economic journals, create abstracts and posters for conference presentations, prepare and present study results to payer advisory boards, and assist in writing FDA reports, among others. The intended audiences include the scientific literature, payors, healthcare providers, regulators and otherinternal and external stakeholders.
- Contribute to strategic planning, protocol development, initiation and monitoring of studies, including health economics, epidemiology and health outcomes, including studies for both marketed products and those in development.
- Develop and conduct observational studies, including database studies and surveys, in special populations including, but not limited to, pediatric and geriatric patients.
- Use epidemiologic and health outcomes research to contribute to disease understanding of targeted indications, comorbid conditions and adverse events for marketed products, those in development, and potential in-licensed products.
- Develop, write, review, and submit scientific publications, regulatory reports, and other written documents for ongoing and completed studies within the Medical Affairs Strategic Research (MASR) department at Purdue Pharma L.P.
- Present findings from research studies to internal and external audiences, including regulators, HCPs, payors, and the scientific community through publications and presentations.
Topics for both studies and publications of interest include, but are not limited to:
- Epidemiology studies to characterize disease states, treatment populations, and patient populations
- Health outcomes and health economics studies
- Studies describing prescribing practices for marketed products
- Benefit:risk assessment for various products
- Validation of diagnostic algorithms using diagnosis and procedural codes against the gold standard of medical chart review
- Patient characterization for new and existing products and disease areas.
Education and Experience Requirements
- PhD in Health Economics, Public Health, Epidemiology, or related field; with 5+ years of experience
- or Master’s Degree in Epidemiology plus 10+ years of relevant experience
- At least 5-10years of hands-on experience in health economics, epidemiology or outcomes research in an academic, clinical, consulting, or industry setting. This should include experience with observational study design and analysis.
- Experience designing and conducting observational analyses in healthcareclaims and national surveillance databases
- A history of publications in peer-reviewed scientific journals and/or other scientific writing examples
- Experience with regulatory interactions a plus.