Apply

The application packet includes the candidate’s CV, a cover letter, and a research statement. Please see the list of open positions below for additional details on application requirements for each of the positions.

For more information, contact the fellowship director Dr. Florence Bourgeois at florence_bourgeois@hms.harvard.edu.

Available Fellowship Opportunities

DATA SCIENCE USING REAL-WORLD DATA

Summary

The Harvard-MIT Center for Regulatory Science, in collaboration with the Department of Biomedical Informatics at Harvard Medical School, invites applicants for a postdoctoral fellowship focused on the use of real-world data to examine drug-drug interactions. The fellow will be based in the Avillach Lab, an interdisciplinary research group focused on the development of cutting-edge techniques for the integration of multiple heterogeneous biological and clinical cohorts with the overarching goal of supporting individualized data-driven healthcare. 

The fellowship project will develop new signal detection algorithms using data mining techniques in real-world healthcare data derived from claims and electronic healthcare records. The project will aim to identify potential pharmacovigilance signals concerning drug-drug interactions across multiple diseases and syndromes.

Project Details
The application of healthcare claims data and electronic health records for use in pharmacoepidemiological studies is booming. Drug–drug interactions can be identified by mining such databases, including adverse drug reactions (ADRs) resulting from the prescription of a combination of drugs (CADRs), considered a special class of drug-drug interactions. While many ADRs can be anticipated and hence avoided, CADRs are highly complex and challenging to identify and, as a consequence, have not been well studied. CADRs may represent as many as 30 % of unexpected ADRs and their elucidation is of particular interest to the FDA. The fellowship project will develop new signal detection algorithms using data mining techniques in real-world healthcare data derived from claims and electronic healthcare records. The project will aim to identify potential pharmacovigilance signals concerning drug-drug interactions across multiple diseases and syndromes.

Research activities include, but are not limited to:

  • Extracting and analyzing information from a nationwide claims database including 67 million subjects
  • Extracting and analyzing information from healthcare records in an academic pediatric hospital including 1.8 million patients
  • Developing and testing methods to detect adverse drug reactions from billing codes, drug prescriptions and lab value results
  • Disseminating findings through national and international conferences and in peer-reviewed scientific publications

BASIC QUALIFICATIONS

  • PhD in computer science, engineering or a related field
  • Expertise in SQL query language
  • Expertise in R or Python programing languages

APPLICATIONS PROCEDURE AND REQUIREMENTS
Please include the following in the initial application:

  • Curriculum vitae
  • Cover letter 
  • 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

Selected candidates will be asked to provide letters of reference.

POSITION DESCRIPTION
Host Institution: Harvard Medical School
Appointing Department: Harvard Program in Therapeutic Science
Research Laboratory: Paul Avillach
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 considerations 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
Paul Avillach, MD, PhD |  paul_avillach@hms.harvard.edu
Department of Biomedical Informatics 
10 Shattuck Street, Boston, MA 02115 

PHARMACEUTICAL POLICY

Summary

The Harvard-MIT Center for Regulatory Science at Harvard Medical School, in collaboration with the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, is seeking a post-doctoral research fellow to work at the intersection of regulatory science, prescription drug use, and pharmaceutical policy.

We are seeking candidates with quantitative and/or qualitative research skills to examine regulatory science issues relating to prescription drug development, clinical testing, and use, which could include the following domains:    

  • Biosimilar testing, regulatory approval, and utilization
  • Post-FDA approval drug testing, safety programs, and “real world” use
  • Rare disease drug development, testing, and use

BASIC QUALIFICATIONS
Individuals with doctoral degrees (Ph.D., M.D., Pharm.D., J.D., or equivalent) with training and/or experience in pharmaceutical health services research, pharmacoepidemiology, or pharmacoeconomics.

APPLICATIONS PROCEDURE AND REQUIREMENTS
The initial application should include:

  • A curriculum vitae
  • A cover letter with a description of relevant research experience, subject interests for the fellowship, and career goals.
  • A writing sample (preferably a peer-reviewed publication)

Selected candidates will be interviewed and asked to provide 3 references.

POSITION DESCRIPTION
Host Institution: Harvard Medical School
Appointing Department: Harvard Program in Therapeutic Science
Research Laboratory: Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital 
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 considerations 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

Ameet Sarpatwari, PhD, JD | asarpatwari@bwh.harvard.edu
Assistant Director, Program On Regulation, Therapeutics, And Law (PORTAL)  Assistant Professor of Medicine, Brigham and Women’s Hospital and Harvard Medical School 
1620 Tremont St. Suite 3030
Boston, MA 02120
Phone: 617-278-0930

MACHINE LEARNING AND NATURAL LANGUAGE PROCESSING

Summary 

The Harvard-MIT Center for Regulatory Science, at Harvard Medical School, in collaboration with the Machine Learning for Medical Language Lab at Boston Children’s Hospital, is seeking a post-doctoral research fellow to contribute to cutting edge research in the field of machine learning and natural language processing for regulatory science applications.

We are seeking candidates who can develop analytical tools to predict device safety and effectiveness using FDA pre-market and post-market databases. This is an opportunity to participate in high-impact work that will allow regulatory agencies to analyze a range of medical device data to identify trends and safety signals, assess device performance across different device types, and analyze data-related workflows to inform process improvements in the future.

BASIC QUALIFICATIONS

  • Candidates with a PhD degree in Computer Science, Math, Physics, Engineering, Statistics or a related technical field, with interest in biomedical applications, will be an excellent fit. However, we encourage candidates from a variety of backgrounds to apply, if their experience and interests match the project goals.
  • Experience in research, including ability to plan and carry out research experiments and projects
  • Candidates with experience in the areas of machine learning, natural language processing/computational linguistics, and medical terminologies/ontologies are strongly encouraged to apply.
  • Programming experience in computer programming languages (e.g., Python, Java, etc)
  • Strong written and oral communication skills
  • Ability to work both independently and as a team player

APPLICATIONS MATERIALS

  • Curriculum vitae 
  • Cover letter
  • Research statement describing the applicant’s research interests, including personal objectives
  • Up to 3 publications with clearly stated individual contributions
  • Three letters of reference (will be requested of finalists)

POSITION DESCRIPTION
Host Institution: Harvard Medical School
Appointing Department: Harvard Program in Therapeutic Science
Research Laboratory: Machine Learning for Medical Language Lab at Boston Children’s Hospital under Timothy Miller 
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 considerations 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.

HOW TO APPLY
Interested candidates should email their applications materials to: 
Prof. Timothy Miller, PI Machine Learning for Medical Language Lab 
tim.miller@gmail.com

NEUROSCIENCE

Summary

The Harvard-MIT Center for Regulatory Science is seeking a fellow with training or expertise in the neurosciences. 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.

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

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 considerations 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 | Florence_Bourgeois@hms.harvard.edu
Co-Director, Harvard-MIT Center for Regulatory Science 
Associate Professor of Pediatrics, Harvard Medical School

REGULATORY SCIENCE – BROAD CALL

Summary

The Harvard Program in Therapeutic Science (HiTS) invites applications for a fellowship position at the Harvard-MIT Center for Regulatory Science (CRS). The fellow will join a cohort of highly motivated Regulatory Science Fellows with diverse backgrounds and expertise to conduct interdisciplinary research with broad applications to medicine and public health and contribute to a thriving regulatory science community.

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.

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) with training or experience in a relevant field such as pharmacoepidemiology, biostatistics, epidemiology, regulatory law, health policy, or pharmacoeconomics

APPLICATION PROCEDURE AND REQUIREMENTS

Please include the following in the initial application:

  • Curriculum vitae 
  • Cover letter with up to five (and at least 2) 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 considerations 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 | Florence_Bourgeois@hms.harvard.edu
Co-Director, Harvard-MIT Center for Regulatory Science 
Associate Professor of Pediatrics, Harvard Medical School