Clinical Associate Professor, Environmental Health Sciences, Florida International University; Former Postdoc, Department of Pharmacology; 2003-2005
Interview By Tanay Desai, PhD
Postdoctoral Fellow, Dept. of Pediatrics
Dr. Terrilyn Richardson is an Investigator in Translational Toxicology, with the Novartis Institutes for Biomedical Research (NIBR), within Preclinical Safety. In her role at NIBR,she performs toxicology studies for safety profiling and assessment for drug discovery and development. Dr. Richardson received her Ph.D. in Environmental Toxicology from Mississippi State University in 2001, and was a postdoctoral fellow at Emory from 2003 to 2005. We spoke about her experiences along her career path, where she transitioned from being a bench scientist to her current position as a preclinical Study Director and Study Monitor.
What was your research focus at Emory?
I took a position here since my husband, Dr. Jason R. Richardson, was a postdoc with Dr. Gary Miller in Whitehead. By then I had been a postdoc for about two years at the University of Kansas Medical Center. My work at Emory in the Dept. of Pharmacology involved investigating inflammation using mouse models in the lab of Dr. Edward Morgan.
How did you make the transition from postdoc into industry?
After two years at Emory, I moved to New Jersey when my husband chose a faculty position at Rutgers University (then University of Medicine-Dentistry New Jersey). While working at UMDNJ, I spent about 7-8 months looking for industry jobs and found that it was difficult to get a foot in the door without previous industry experience. Eventually, a Rutgers colleague introduced me to a contact in Regulatory Affairs at Novo Nordisk when a Regulatory Associate position in their Princeton location opened up. It turned out that my eventual Regulatory Affairs supervisor also had a Ph.D. in Toxicology, as I did. This allowed us to begin an interesting dialogue on drug development from regulatory compliance standpoint.
Was it difficult to make the transition from the bench to Medical and Regulatory Affairs at Novo Nordisk?
My prior experience helped in the sense that I had an eye for the scientific content of these regulatory documents in this role. The rest was learning on the job really. My work at Novo Nordisk involved working with several different teams such as, marketing, sales and legal, with the aim of supporting marketing claims. I helped evaluate promotional materials for use by pharmaceutical sales representatives, and maintained up-to-date knowledge of laws, regulations and policies enforced by the Federal and State governments related to advertising and promotion of pharmaceuticals and devices.
And your subsequent position was in Regulatory Affairs?
Yes, after about a year and a half at Novo Nordisk, I moved to an Assistant Director of Regulatory Affairs position with Hurley Consulting Associates in Chatham, NJ. While the job profile here was slightly different from the one at Novo Nordisk, it essentially entailed maintaining and assembling technical documentation, applications and interpreting FDA guidelines. This meant working closely with the CEO, the Quality Committee and interfacing with the Director of Regulatory Affairs.
Please tell us a little bit about your role at NIBR.
My current job involves two different sets of responsibilities- Study Director and Study Monitor. As a study director, I design, conduct and interpret in-life non-clinical safety studies of drug candidates at NIBR to support investigational (IND) and new drug applications (NDA). Basically this means running safety studies in rodents and non-rodents, leading up to drug applications. My focus areas are drugs in the oncological and cardiovascular medical sphere. My role as a study monitor, on the other hand, involves interfacing with study directors at contract research organizations that handle pre-clinical studies for drugs in the Novartis pipeline
What is a day in the life like for a Study Director or Monitor?
I don’t actually spend time at the bench anymore. Rather, my work involves overseeing a team that performs the studies, obtaining approvals from various departments such as the Animal Care and Use Committee, the Protocol Review Committee, and the Head of Toxicology at NIBR, and preparing study protocols. Further along the work-flow, I then tabulate study results and prepare written reports with specified timelines for completion. The aim here is to conduct studies in accordance with applicable regulations (internal guidelines, FDA Good Laboratory Practice for Non-Clinical Studies, OECD etc.).
So, do you spend time performing studies?
No, a lead technician handles the actual physical work, including dosing of animals or blood collection. A portion of my responsibilities involves coordinating completion of work between different departments, such as clinical and anatomic pathology and toxicokinetics, updating PCS Management, and attending scientific seminars and meetings. So, I am no longer in the lab or at a bench!
Are there specific degrees that are preferred for regulatory affairs positions? Or certification that one can attain to be more competitive?
It entirely depends on the nature of the position. If the job involves regulatory work for Chemistry, Manufacturing and Controls (CMC), then a Chemistry degree would be a good fit. There are no hard and fast preferences. I personally did not attain Regulatory Affairs certification (RAC) or take courses prior to joining Novo Nordisk. Senior Manager-type positions do tend to have Ph.D.’s. at this level. Websites such as raps.org or diaglobal.org can be useful for insights into the drug development process, and associated regulatory affairs literature.
Were you able to access resources at Emory to aid your job search?
We had no operational Office of Postdoctoral Education at the time. I did attend several meetings for the Society of Toxicology and kept talking to people there. As an introvert, I always found it difficult to approach people and network effectively, but you get better with time. Making my CV stand-out was another bottleneck. I would recommend networking as much as possible. In hindsight, I went into most of my early interviews quite unprepared. Subsequently, I began learning as much as I could about the company profile online prior to the interview. Those are three pieces of advice that I could share- network as much as you can, work on getting your CV to stand-out, and research the companies that you seek out in depth.
This interview was published in July 2015.