Clinical research and regulatory affairs careers

What is clinical research?

Clinical research work is directly related to patient outcomes, such as in clinical trials. Clinical trials can be run either by companies (ex: biotech or pharmaceutical) or in academia (ex: university). According to Katie Cottingham from Science, clinical research teams can be led by PhDs, with no requirement to have an MD degree. Sarah Misenko, who writes for the Rutgers iJOBS blog, discusses the broad nature of clinical research, including roles like clinical trial managers and medical writers, as well as some tips for transitioning into this industry for PhDs.

Toby Freedman’s Book “Career Opportunities in Biotechnology and Drug Development” also includes a chapter on Clinical Development (Ch. 10), where many of the clinical research jobs are found. Some of these subfields include: clinical development, biometrics, and clinical support.

 

What is regulatory affairs?

Regulatory affairs (RA) scientists are involved with overseeing the process of getting a drug through clinical trials and onto the market. Since every step in the process of product development is highly regulated, those in RA work at each step to move a drug from research and development through FDA approval. They act as liaison between companies and the Food and Drug Administration (FDA). David Jensen writes for Science about one of the functions of regulatory affairs scientists: “Scientists working in RA cross the border between strategy and operations in the important area of product labeling--that little folded piece of technical fine print that is in every prescription you get from the pharmacy.”

Read more about this career from Nancy Volker’s Science article “All in the Details: Careers in Regulatory Science.” The FDA also has a webpage Regulatory Science with details on this field and the structure at the FDA. 

To learn more, check out chapter 12 of Toby Freedman’s book “Career Opportunities in Biotechnology and Drug Development.

 

What does a career in clinical research/regulatory affairs look like?

PhD Career Guide discusses some of the roles, entry points, career progression, and compensation expectations for careers in regulatory affairs. Some of the responsibilities of RA is writing and working in teams. The scientific background of PhDs is useful for the FDA product approval process; more information in Toby Freedman’s book. 

For clinical research, understanding on clinical trial processes is crucial, including Good Clinical Practice (GCP). Since these trials are so highly regulated, everyone on the team must have a thorough understanding of the guidelines that clinical trials must follow. This aspect of the job is discussed by both Sarah Misenko (Rutgers iJOBS Blog) and Vicki Ronaldson (BiteSizeBio).

Learn more about what clinical research scientist’s job looks like from Vicki Ronaldson.

 

What are some job titles for those who work in clinical research/regulatory affairs?

  • Chief Regulatory Officer
  • Clinical Operations Associate Director, Director, or VP
  • Clinical Program Director
  • Clinical Project Assistant
  • Clinical Research Associate (CRA)
  • Clinical Research Coordinator
  • Clinical Research Manager
  • Clinical Research Scientist
  • Clinical Trial Coordinator
  • Clinical Team Leader
  • Manager of Regulatory Operations
  • Medical Writer (in regulatory affairs)
  • Product reviewer (or Medical Reviewer)- works on the FDA side of product approvals
  • Regulatory Affairs Associate
  • Regulatory Affairs Liaison- a very common position that represents the company to the FDA during submission process and acts as a liaison between them
  • Regulatory Affairs Specialist
  • Regulatory Scientist

 

How to transition into clinical research/regulatory affairs?

 

Get experience:

 

Find your community

 

Examples of organizations that hire PhDs

  • Food and Drug Administration (FDA)
  • CMR London
  • Clinical research scientists can work in hospitals, universities, or pharmaceutical companies. Some examples here.

 

Is the clinical research/regulatory affairs field a good fit for you?

Good question! Find out by completing the AAAS's My Individual Development Plan Assessment Tool, which OCPD co-created. Answer three assessments and it will calculate and compare your skills/interests/values responses to key factors for 60 different career paths within 20 different career categories that are options for you as a scientist (including consulting!). Click on the image to the left to see a sample report.

 

Ready to start your job search?

ProClinical blog on how to get a job in regulatory affairs

Take a look at some sample job descriptions.

 

 

Internship/Fellowship examples:

**these are meant to serve only as examples. Actual job listing may be closed.

 

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