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Occupational Summary

The two-year Measurement and Regulatory Science (MaRS) Fellowship is the only program in the United States where you get on-the-job training while building and strengthening your research skillset in COA, stated-preference research, and patient-centered research.

Fellows will:

• Engage in coursework and self-directed research projects, and are exposed to real-world regulatory issues related to patient-centered research
• Train one-on-onewith expert Duke faculty who’ve developed measurement tools that are being used globally
• Get real-world experience through mentor-guided industry research
• Develop research skills that are disease- and setting- agnostic and can answer regulatory questions
• Build a professional network from our industry partners andDuke’s world-renowned faculty

MaRS Fellowship Core Skillset

• Designing, selecting or evaluating clinical outcomes assessments (COAs)
  • Best practices for survey design
  • Measurement theory and models
  • Qualitative methods for concept elicitation
  • Qualitative methods for cognitive testing
  • Quantitative methods for evaluating psychometric properties of COAs
• Integratin g COAs in clinical trials
  • Endpoint positioning of COAs
  • Analytic considerations for COA endpoints
• Survey methods for valuing outcomes and assessing preferences
  • Random-utility theory and models
  • Economic models for choice under uncertainty
  • The use of preference data for patient-centric benefit-risk analysis
• Patient-focused drug and device development
  • Engagement of stakeholders throughout development programs
    • Best practices for patient engagement
  • Conceptual models relevan t to a development program (e.g., of disease, endpoint model, context of use)

Work Performed

The term of the appointment is two years. Eighty percent of the time in Year 1 is spent training in Durham, NC withthe Postdoctoral Appointee functioning under the supervision of a Duke faculty mentor, while the remaining 20% is spent receiving mentoring from an industry partner. In Year 2, 80% of the Fellow’s time is spent training with an industry partner, and Duke faculty will provide mentoring for the remaining 20%.

Year 1 is focused on strengthening skills via training and participation in ongoing studies involving COAs. During this time, fellows will attend graduate-level courses offered through Duke's Department of Population Health Science's graduate program or other courses offered throughout Duke. The Fellow will participate in a mentored research project on health outcomes measurement.

Year 2 is focused on real-world,experiential patient-centered research. The Fellow will continue to conduct a mentored project that is both related to patient-centered research and can contribute to regulatory decision-making and policymaking, under the guidance of an industry mentor and a Duke faculty mentor. At the end of the two years, the postdoctoral fellow is ready to transition to work inpatient-centered research in an industry or regulatory science setting.

General Expectations:

The appointment involves substantially full-time research or scholarship, and may include guest lecturing responsibilities. The appointment is generally preparatory for a full-time research career in industry or regulatory science. The Appointee is expected to publish the results of his or her research or scholarship during the period of the appointment.

The Postdoctoral Appointee should hold a PhD or equivalent doctorate (e.g. ScD, MD) in public health, psychometrics, education measurement, biostatistics, medical sociology/anthropology, nursing, medicine, or related fields. Candidates may also need to move to the Durham, NC area for the first year of the program. Candidates with non-US degrees may be required to provide proof of degree equivalency.

1.      A candidate may also be appointed to a postdoctoral position if the candidate has completed all of the requirementsfor a degree but the degree has not been formally conferred: in this case, the candidate may present evidence of completion of the degree requirements, together with a statement documenting the date on which the degree is to be conferred. If the degree is not conferred by this projected date, the postdoctoral appointment may be terminated.

2.       Note for international candidates: Generally,immigration classifications (e.g., H-1B, J-1, etc.) require that the requisite degree be conferred before a petition can be filed or a visa document issued to sponsor the individual.

The Fellow agrees to conform to standards of responsible conduct in research and comply with good scholarly and research practices. They will maintain records of research activity, which remains the property of Duke University upon termination.

The Fellow will maintain open and timely communication with the faculty and industry mentor regarding all facets of their research activities. The Fellow is encouraged to consult the AAMC Compact between Postdoctoral Appointees and their Mentors for suggested guidelines for the Postdoctoral Appointee-mentor relationship. Additionally, the Fellow will promptly disclose, to their mentor, the possession and desire to distribute materials, reagents, software, copyrightable and potentially patentable discoveries derived from the Postdoctoral Appointee's research.

Minimum Qualifications
Education

See job descriptionfor education requirements.

Experience

See job description for requirements.

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