Senior Research Director, Methods Standards

Position: Senior Research Director, Methods Standards
Reports To: Senior Vice President
Date Prepared: March 19, 2013
FLSA Status: Exempt
Classification: Regular, Full Time

Position Summary

The Senior Research Director, Methods Standards, is responsible for oversight of the development of comparative effectiveness research methods standards within an exciting new initiative at CMTP, the Green Park Collaborative – USA (GPC-USA). GPC-USA is a multi-stakeholder forum that will be developing condition-specific methodological standards to guide the generation of evidence needed to inform coverage and payment decisions in the United States. The GPC-USA will accomplish this important objective by providing a neutral, trusted forum within which payers, life sciences companies, patients, clinicians, researchers and other stakeholders can reach consensus on how best to design studies that demonstrate real world effectiveness and value. In 2013, the work of the GPC-USA will focus on methodological standards for comparative effectiveness research in oncology and diabetes.

The Senior Research Director, Methods Standards, will provide conceptual and scientific leadership for the development of CMTP’s condition-specific methodological standards, known as Effectiveness Guidance Documents (EGDs). EGDs are developed through a multi-stakeholder collaborative process and are intended to provide a range of decision makers with well-defined standards for prospective study design that can also be used to assess the quality and relevance of clinical studies. EGDs are analogous to Food and Drug Administration guidance documents. Whereas the latter provide guidance for regulatory approval, EGDs focus on the design of clinical studies to support decisions by patients, clinicians and payers.

Responsibilities

  • Leads the development activities and ensures accuracy and clarity of condition-specific methodological standards.
  • Works closely with the GPC-USA Senior Program Director to contribute to unit leadership and vision.
  • Designs, coordinates and conducts interviews, surveys, literature reviews, and policy analyses to support GPC-USA projects and needs.
  • Develops solutions to complex health services research and health policy problems requiring a high degree of ingenuity, creativity and innovation.
  • Participates as a member of the Leadership Team in creating and reinforcing alignment to the organization’s strategic goals and purpose.
  • Plays an active role in helping to secure grants or contracts to enable the organization to maintain financial sustainability.
  • Supervises and provides mentorship to a team of managers, associates and contractors to complete the research, which may include line supervision.
  • Provides technical assistance to other CMTP staff regarding designs proposed for conducting comparative effectiveness research.
  • Creates a positive environment that encourages teamwork, cooperation and collaboration.
  • Leads the preparation of peer-reviewed manuscripts and reports for CMTP workgroups and external audiences.
  • Other duties and tasks as assigned.

Knowledge and Experience

  • Medical degree or Ph.D. in epidemiology, public health, or related field
  • Minimum of ten years professional/clinical experience and background in one or more of the following: clinical trial design, prospective observational study design, or health technology assessment.
  • Minimum of ten years experience in managing projects and mentoring junior research staff.
  • Demonstrated record of comparative effectiveness research-related peer-reviewed publications and presentations at national meetings.
  • Ability to conceptualize, organize and implement complex multi-year clinical research studies.
  • Demonstrated ability to critically appraise methodological strengths and weaknesses of clinical studies.
  • Skill in analyzing issues and developing/presenting facts, recommendations and solutions in clear, concise and logical terms.
  • Ability to set goals, measure progress, and meet deadlines while managing multiple projects simultaneously.
  • Proven leadership skills and commitment to working in a team environment in an entrepreneurial setting.
  • Demonstrated breadth of knowledge of health care issues, healthy policy and health care programs, particularly with respect to issues regarding medical technology.

Physical Demands and Work Environment

  • Continuous standing, walking, and sitting throughout the day.
  • Some travel may be required, including out of state.
  • Some light lifting of up to 25 pounds may be required.
  • Continuous typing and viewing of a computer screen may be required.
  • Must be able to calmly and effectively work with high stress situations.

Send cover letter, resume and writing sample to:

Ty Williams
Manager, HR & Administration
Center for Medical Technology Policy