Postdoctoral Fellow

Employer
Harvard - MIT Center for Regulatory Science
Location
Boston, Massachusetts
Salary
Commensurate with experience
Closing date
Nov 26, 2021
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ABOUT THE FELLOWSHIP PROGRAM

The Harvard-MIT Center for Regulatory Science is a partnership between Harvard, MIT and the FDA, focused on building innovative approaches for the development and evaluation of medical products. Working across academia, industry, and government institutions, the Center promotes regulatory science through research and education programs, uniting stakeholders under a common mission: to promote optimal patient health outcomes through biomedical innovation and the availability of safe and effective treatments.

Regulatory science brings together a range of scientific disciplines to assess the quality, safety, and effectiveness of therapeutics, helping to inform regulatory decision-making over the lifecycle of drugs, devices, and vaccines. The Regulatory Science Fellowship Program draws individuals with diverse expertise who are passionate about developing and applying novel methods in therapeutic science and contributing to the multi-disciplinary community of the Center.

For this position, the fellow will work with faculty at Harvard Medical School, Harvard-Affiliated Hospitals or MIT, and benefit from interactions and collaborations with FDA scientists on a project-specific basis. The fellow will be expected to participate in international conferences and publish conference and journal papers.

Potential areas of interest include the following topics, among others:

  • Use of biomarkers for development of novel neurological indications and requirements for clinical validation 
  • Creating a regulatory framework for wearables and other digital technologies for use in diagnostics, monitoring of treatment outcomes, and disease maintenance among patients with neurological conditions
  • Development of more patient-centric and patient-rated outcome measures that can be used as approvable endpoints in the development of CNS agents
  • More flexible approaches to trial designs to expedite development of therapeutics for neurological diseases

Unique aspects of this fellowship program include:

  • Access to FDA scientists and collaborations on FDA projects
  • Participation in an established multi-disciplinary community, enabling educational experiences and research activities outside of a single field of expertise
  • Access to clinicians and investigators at multiple large healthcare centers, providing opportunities for research projects with direct medical applications

BASIC QUALIFICATIONS

  • Individuals with doctoral degrees (MD, PhD, PharmD, JD, or equivalent) and training or experience in clinical neurology or psychiatry, basic neuroscience, or in a relevant field such as pharmacoepidemiology, epidemiology, or health policy

APPLICATION PROCEDURE AND REQUIREMENTS

Please include the following in the initial application:

  • Curriculum vitae 
  • Cover letter with up to five faculty members with whom the applicant would be interested in working
  • Research statement describing the applicant’s research interests, including a description of the relevance to regulatory science
  • Writing sample or up to three relevant publications

If selected to submit a full application, candidates will be interviewed and asked to provide:

  • 3 letters of reference
  • Project description (3 pages maximum) that includes justification for the work, specific research objectives, proposed methods, and the project’s broader relevance and implications for regulatory science
    • The project description may be developed jointly with the mentor following identification of a faculty mentor after submission of the initial application

POSITION DESCRIPTION

Host Institution:  Harvard Medical School 

Appointing Department: Harvard Program in Therapeutic Science

Research Laboratory: TBD

Location:  Boston, MA 

Category: Scientist

Other responsibilities: no administrative or teaching obligations

Duration of fellowship: 2 years

EEO STATEMENT

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions or any other characteristic protected by law.

CONTACT

Florence Bourgeois, MD, MPH

Co-Director, Harvard-MIT Center for Regulatory Science  

Associate Professor of Pediatrics, Harvard Medical School

Florence_Bourgeois@hms.harvard.edu

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