Alternative Science Careers

How did you get a position at the FDA? Describe your career path and the factors that led you to this alternative career?

I received a Ph.D. in Pharmacology,  (my thesis was based on studies of the metabolism of nicotine in laboratory animals), and followed that with a post-doctoral fellowship at a research institute funded by the chemical industry.  The choice of post-doc was driven mainly by a realization by me and my thesis advisor that I would not be an academic researcher.  I then went to work in the Toxicology department at Dow Corning Corporation in Midland, MI. There I developed the lab’s bioanalytical capabilities to support pharmacokinetic studies. That lab followed the FDA’s Good Laboratory Practice regulations (GLPs), and piqued my interest in Quality Assurance (QA) as a career. After two years in the Toxicology department, I took a position as a Reliability Engineer in the QA department of Dow Corning’s medical products manufacturing site. That was a definite career shift, and the decision to make the change came from a realization that I was not meant to be a bench scientist, as well as a desire to learn more about Dow Corning as a company.  The shift to manufacturing expanded my world in terms of understanding business processes, manufacturing, quality control/quality assurance, etc.  In fact, while in that position I completed one year of an Executive MBA program, but realized that I was not meant to be a business executive, either. The manufacturing plant was my introduction to another set of FDA regulations: Good Manufacturing Practices (GMPs), which led to a desire to pursue Regulatory Affairs as a career.  Unfortunately, Dow Corning as a company only had two Regulatory Affairs positions, so the opportunity to make the career change would have to come with a new employer.

The constant focus on adherence to FDA GMP regulations, an outside training at which FDA Investigators spoke, family health issues, and a job opening near my hometown in PA, led me to take an Investigator position with the FDA in 2000. At that time I also learned about the opportunities for Ph.D. scientists as Commissioned Officers in the USPHS Commissioned Corps.  The PHS CC offers 20 year retirement, military health, education and leave benefits. An important criterion for promotion in USPHS is job mobility, and I have been mobile ever since.

After two years with the FDA field office in Harrisburg, PA, I took a position with the U.S. Environmental Protection Agency (EPA) in Crystal City, VA, where I worked as a Chemical Review Manager for the Office of Pesticide Programs. I served as a project manager for teams of EPA scientists who assessed the safety of marketed pesticides. I was responsible for reviewing and summarizing their risk assessments into public documents that presented risks from pesticide use as well as steps that EPA would ask pesticide manufacturers to take to mitigate those risks.  A large part of my success in the position was my ability in understanding the science behind the risk assessments, and negotiating with pesticide companies regarding mitigation strategies.

After three years at EPA, I returned to FDA, this time in Rockville, MD, to serve as a Regulatory Review Officer in the Division of Scientific Investigations (DSI), Center for Drug Evaluation and Research. There were two primary reasons for making this job change:  one, I needed to advance in terms of job classification, and two, I wanted to return to the area of Good Clinical Practice regulations, which I enforced as a Field Investigator.  While at DSI, I reviewed inspection reports and took part in inspections of clinical trials and nonclinical toxicology studies. The most memorable times in that position were inspection trips to Turkey, Italy and Germany.

After three years with DSI, I moved to my current position as a Pharmacology/Toxicology Reviewer with the Division of Antiviral Products in CDER. I took this job mainly because I now have two young children and the travel requirements of my previous position were too great.  As a Pharm/Tox reviewer, I receive final reports from animal toxicology studies performed by/for pharmaceutical companies. I review those nonclinical study reports in order to identify toxicological findings related to administration of investigational drugs. Based on the adverse effects and the dose levels at which they occurred, I recommend safe starting doses for first-in-human clinical trials.

I have been at this position for only a year, so the position is still challenging and I am learning all the time.

What does your typical work day look like?

On a typical day I will have a study to review, say for example a 6-month repeat dose study in rats.  We have a review template that we use so that our review formats are consistent, and I use that template to step through the study.  I start with the sponsor’s summary, to get a feel for any significant toxicological findings that they identified, and use that information as a basis for looking at the raw data in the report.  In general terms I am checking to see that the conclusions drawn by the sponsor are supported by the study data.  If not, I need to identify discrepancies and bring them to light in my report.

What part of your job do you find the most enjoyable? least enjoyable? most challenging?

I like the feeling of accomplishment from completing a study review, and I get plenty of opportunity for that.  Least enjoyable for me is presenting my summary at team meetings, just because it can be an awkward balance between droning on and on and being so brief that the important aspects of my review are missed. Most challenging is knowing if seemingly insignificant toxicological findings might actually be a signal of human toxicity.  We try to be conservative in our recommendations without unnecessarily slowing the drug development process.

What particular skills and talents are most essential to be effective in your job?

CDER’s Office of New Drugs is split into various divisions that concentrate on different drug indications (e.g., antivirals, metabolic/endocrine, gastroenterology).  In most divisions (antivirals being the exception that I am aware of) Pharm/Tox Reviewers need to have an understanding of the mechanism of action of the class of drugs that they are working on, because they are expected to comment on the efficacy of the drug in animal models, as well as the safety.

Other than the scientific knowledge, skill in technical writing and verbal presentation of technical information are important.

How can graduate students obtain necessary experience needed to get into the field?

In general Ph.D.s have the necessary experience.  Some supervisors prefer new Ph.D.s, others like to have individuals with post-doctoral experience.

What is the typical career path in this field?

I’m new in the position, so I don’t have direct experience with the career path forward.  However, my impression is that Pharm/Tox Reviewers often stay with the FDA for their careers, as the position allows for an employee to reach the level of GS-14 (currently I would estimate the average salary of a GS-14 at approximately $120,000/year [refer to http://www.opm.gov/oca/10tables/index.asp]) without supervisory responsibilities. Another option after several years is to take a position, often a management position, in industry.

How does someone find out about job opportunities?

The best way is to search for Pharmacologist positions with the FDA on the USAJobs website [http://www.usajobs.opm.gov/]

What advice do you have for someone interested in this field?