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Director, Office of Clinical Evidence and Analysis

Fda

This is a Contract position in Silver Spring, MD posted December 28, 2019.

?OCEA develops policy and provides program support for clinical trials, biostatics, real-world evidence, epidemiological analysis, and outreach and collaboration with the healthcare and scientific communities, as well as other stakeholders. OCEA is also responsible for the development and implementation of policies and protocols in support of capturing and reporting scientific and patient related data from interventional clinical trials, the protection of human subjects, and for the provision of regulatory oversight medical device clinical and research investigations to ensure good laboratory and clinical practice in support of premarket reviews. ?

?As the Director of OCEA, you will serve as the principal advisor and technical authority to the (OPEQ) Principal Deputy Director on all matters impacting the responsibilities of the Office. You will be relied upon to provide strategic guidance and oversight for all Office activities, technical, administrative, and budgetary, in support of medical device innovation, safety, and effectiveness. Additionally, as the Director, you will serve as an expert liaison between the Center and the medical device manufacturing industry, as well as the scientific and healthcare communities. Further, you be charged with accelerating the innovation of new medical devices through the provision of clinical and real-world evidence and the development of new regulatory pathways.

The Director will:

  • Ensure all Office activities, goals, and objectives align with OPEQ and Center strategic priorities
  • Effectively contribute to the advancement of the mission, vision, and values of OPEQ and the Center
  • Represent the Center and Office at internal and external meetings
  • Cultivate and maintain relationships, internally and externally, in support of the Center’s mission
  • Effectively communicate complex scientific and clinical presentations to diverse audiences to include, patients, providers, FDA leadership, medical device manufacturers, scientists, and policy makers
  • Contributes scientific and/or clinical expertise to regulatory reviews and new policy development
  • Lead OCEA’s continuous quality improvement
  • Serve as the expert technical and clinical advisor to the OPEQ Principal Deputy Director
  • Provide professional development opportunities for all Office subordinate leaders, as well as serve as a mentor for less experienced managers and supervisors.
  • Creates and sustains a strong and dynamic culture within the Office including organizational agility, staff empowerment, and collaboration.?