Clinical Trials Day Countdown: Meet Karen
As part of our countdown to Clinical Trials Day, we're interviewing some of our team members. Follow along here to meet our team and learn about their experiences within clinical research!
Today we're interviewing Karen Pypniowski, Vice President, Feasibility & Site Operations.
When did you begin working in clinical research and expand to where you are today?
Nearly everyone I have worked with has accidentally discovered research as a profession. Graduating from Villanova in 1996 with my Bachelor of Science in Nursing was, believe it or not, a time of an overage of nurses. We were basically “fighting each other” in the parking lot for jobs. I began working as a senior facility nurse shortly after my graduation. When I became pregnant and did not want to work nighttime/weekend shifts anymore, I caught sight of a position for “data managers” at what was then Smith Klein Beecham (SKB). Kelly Scientific, a staffing agency, held group interviews at the SKB location near my home. At my interview, I saw numerous fellow graduates who couldn’t find desirable nursing jobs. We were all applying for this same position. When I arrived home from the interview, I listened to a voice message stating I got the job and could start the following week. This position was my entry into research. Honestly, I wasn’t sure what this position entailed, but looking back after 26 years, this was my springboard into a continually fascinating and ever-changing world of research.
What made you want to work in clinical research (and/or healthcare)?
I wandered into a clinical research interview because of my needs and the competitive nursing market when I first graduated from college. I will instead share why I have changed positions in this industry over my career, which has spanned sales and operations at site organizations, contract research organizations, and pharmaceutical sponsors.
I worked as a data manager at SKB and Astra Zeneca (AZ) early in my research career. I moved up the ranks at AZ and led a team of 12 people in transitioning the CRESTOR studies, a statin to lower cholesterol, from COVANCE back in-house to conduct the final data cleaning/querying and locking so AZ could pull together their submission. This period was pre-digital advances when the process required two large tractor-trailers to pick up all the paper submission documents from the clinical research organization! We worked as a team, sometimes 12-14 hours daily, to manage the paperwork. I fondly recall how the team brought pajamas to change into after the office cleared out, and we ate pizza on the floor while going through all remaining queries and ensuring all data was CLEAN before the lock. Once this project was complete, many of my team members were released as things went back to normal with the day-to-day priorities, which was less enthusiastic, and I sought a new opportunity quickly. Celebrating my first launch party at AZ still warms my heart!
After this experience at AZ, I found a role at US Bioscience which MedImmune acquired, and then closed the Conshocken office where I was based. Due to not wanting to relocate to Maryland, I found a small company CPR (Concepts in Pharmaceutical Research) close to home and looking for a Project Manager. When I read the job description, it was clear I did not have the required experience and did not meet the entry requirement; however, my enthusiasm to learn and excitement to grow my career intrigued the team enough to give me a chance. Still, I managed a team through a data submission to launch, and I knew I could manage research projects, so I applied–I surprised myself as I sailed through the interview job. The company offered me the job of managing three community, hospital, and nursing home-acquired pneumonia studies with Bayer. I engaged with doctors, kept Bayer updated with study progress, managed the CRA team, collected and shared best practices and lessons learned, led the Investigator Meeting presentations, etc.
Shortly after that, I took on a Project Management role at PPD, and because I found out I was pregnant during foundations training in RDU, PPD did not want to present me as the Project Manager to any newly awarded studies only to have to pull me off and re-train someone else during my maternity leave. Therefore, they shifted me into a SWAT team lead role, and I reported directly to the CEO–Dr. Fred Eshelman. My team (12 people covering regulatory, quality, monitoring, and project management) would assess struggling studies and apply additional resources, training, audit prep, template creations, and much more to get studies back on track with no visibility to the sponsor and no further escalation to Dr. E.
I managed this team for six years and worked incredibly close with the head of clinical operations, who moved to another CRO, Pharmaceutical Research Associates (PRA), as the head of Business Development (BD). She recruited me into PRA as a director in BD. This opportunity was a new role and a complete shift in my career away from operations. In year two, I won third in sales on a team of 15+ salespeople. I stayed at PRA for five years and was recruited to another CRO, Worldwide Clinical Trials (WCT), to work in neurology.
Neurology is a passion area of mine. Ever since I was a child, I was fascinated by how the brain was the "hub" for all bodily functions. I would read about the brain and transfer notes from our Encyclopedia Britannica collection into my notebook/diary! Years of working research really came to a momentous achievement last year when the treatment for Alzheimer’s, Legembi™, was FDA-approved. Leqembi is the second of a new category of medications approved for Alzheimer’s disease that target the fundamental pathophysiology of the disease. These medications represent an essential advancement in the ongoing fight to treat Alzheimer’s disease effectively. This was one of the largest studies I ever sold as a BD rep and worked with a team to bring it to fruition. It is an honor to say I was part of that success. For people suffering from Alzheimer’s, this is one step closer to improving their lives.
To learn more about Legembi™ read here: https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment
After my time at WCT, I worked at an eCOA/ePRO provider, then back to a small niche CNS-focused CRO, Peachtree Bioscience. At this point in my career, I wanted a change and reflected on my career experiences. Having worked at CROs, Biotechs, and Pharma, I wondered what it would be like to work more closely with the research conducted at the site level. Immediately after this reflection period, I received a job referral to work at Accel Research Sites as their Vice President of Business Development. I built more structure around business development processes, the team, and the systems.
From there, I moved to my role here at Circuit Clinical. I started at Circuit as the Vice President of CRO Sales, then added in feasibility, and now shifted to the Vice President of Site Operations. At a startup like Circuit, I have learned agility is essential, and my experience wearing many hats has been a critical asset here.
What inspires you about doing clinical research?
Leading and managing people is the heart of my career enjoyment, and overseeing projects to success, whether patient enrollment and retention, data lock, or approval submission; all research work inspires me if it means we are helping people live better lives. The desire to work smarter, not harder, while supporting each other is vital to me in any role, along with the continued and shared desire to bring new treatments and care options to patients in a safe environment. I have continued to seek and enjoy positions with organized chaos throughout my career, but through that, I always strive to share lessons learned and best practices across the teams I work with and lead. Clinical research is challenging, and if we don’t share our learnings and findings, we are doing a disservice to those who need us most—the patients. I want all of us to succeed; for them.