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?
- Career transition stories- clinical research
- PhD in Pharmacology to Regulatory affairs
- Materials from the Nov. 28, 2017 OCPD Program
- To start getting experience while working in an academic lab, consider joining a team that is working on filing with the FDA or a clinical trial submission. You could also take on a role such as clinical trial coordinator or choose a postdoc with clinical research responsibilities.
- UCSF's Advanced Training in Clinical Research Certificate
- Fellowship opportunities:
- Degree programs at universities such as USC and Florida
- Perform a real job task in clinical research or regulatory affairs through a job simulation
- Regulatory affairs courses through TOPRA
- Regulatory Affairs Professionals Society (RAPS) offers a regulatory affairs certificate (RAC)
Find your community
- UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI)- joint venture of UCSF, Stanford, and the FDA
- Has a mailing list, courses, and upcoming events
- Regulatory Affairs Professionals Society (RAPS)
- American Society of Quality
- The Organization for Professionals in Regulatory Affairs (TOPRA, Europe)
- American Medical Writers Association
- Clinical research professional associations
- Drug Information Association (DIA)
- Association of Clinical Research Professionals
- American Society for Clinical Pharmacology and Therapeutics
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- Clinical research resources
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?
Take a look at some sample job descriptions.
This is what a UCSF alum with the title Senior Associate, Regulatory Affairs, had to say when she wrote our office about the opportunity below: “We are fortunate to have an entry-level FTE position open in my department. Ideally, the candidate would have industry experience, however, the company would be interested in someone who has equivalent academic experience, especially those with an advanced degree.”
**these are meant to serve only as examples. Actual job listing may be closed.