One of the many benefits of participating in a fellowship program is the program’s alumni network. The MFN’s alumni work across the country and even serve as program directors and industry preceptors for our current fellows. This week, we would like to introduce Amanda Nguyen, an alumna of the MCPHS/Novartis Clinical Sciences & Innovation (CS&I) Fellowship. After completing her fellowship in June 2018, Amanda accepted a position at her fellowship company and volunteered to serve as one of the MFN’s alumni representatives. This past year, Amanda has organized two alumni panels for our quarterly Conference Series with her co-representative. They have recently helped match our current fellows with 21 fellowship alumni to help review CVs.
Learn about a clinical scientist’s role, and read about Amanda’s reflection on her time as a fellow and how Novartis prepared her to take on the challenges of her current position.
As an Associate Clinical Scientist (ACS) in the Translational Medicine Department at the Novartis Institutes for BioMedical Research, I lead study teams in early phase clinical trials including first-in-human and proof-of-concept studies. This role entails a variety of responsibilities depending on the phase of the study—whether it be start-up, maintenance, or close-out. Clinical scientists are essentially the point person for the study and liaise with internal line functions such as the medical lead, biostatistician, pharmacokineticst, biomarker expert, and regulatory colleagues, and collaborate with external partners such as the site investigators, study teams, field monitors, data management, among other vendors.
During the start-up phase, clinical scientists work with the internal team to draft the clinical trial protocol and site operations manual along with several other study related documents. After choosing the sites and vendors, we train them on the study protocol and then commence study activities. During the maintenance portion, we make sure that the study runs smoothly by ensuring that the necessary assessments are completed and that data is collected appropriately. We review and analyze the data with the internal team before handing it off to upper management to determine whether to proceed to the next step in the development process. Finally, during study close-out, after all of the data has been verified, we lock the database, ensure all of the necessary documents have been collected for the trial master file, and write the clinical study report. Clinical scientists wear many, many hats, but ultimately are responsible for the operations and oversight of the clinical trial.
Looking back at the MCPHS/Novartis Clinical Development Fellowship, I realize that I have grown so much not only professionally, but also personally. I attribute my professional growth to the structure and experiences of my fellowship program, and attribute my personal growth to the relationships I have built with my mentors, colleagues, and friends that I have made through the MCPHS/Novartis Fellowship. Because of the foundation I built during the fellowship, transitioning from fellow to an ACS was a seamless process. I remain on the same study teams and still have strong support from my manager and mentors, which made the transition very smooth. I loved my whole fellowship experience and a few key items stand out in my mind that made the transition easier.
Networking was a huge part of the fellowship in my opinion. I always thought it was a formal process of exchanging business cards and promoting your skills, but networking is simply getting to know your colleagues and peers. It can be as easy as chatting with a coworker on the way to lunch. Networking helped me connect with my colleagues, which helped us collaborate with each other more effectively. The MCPHS fellowship also does a great job to encourage networking by allowing fellows from different companies to collaborate during Conference Series and hosting fun events for current and former fellows to get together. You never know whom you could be working with in the future!
Alongside networking, mentorship throughout the fellowship program also shaped who I have become. During my fellowship, I had a strong network of mentors, whether it be my director, preceptor, former fellows who were in my shoes, or other study team members who all wanted me to succeed. Regular meetings with my mentors facilitated my professional growth because they helped me work on areas of improvement and continued to develop my strengths. My mentors challenged me to be the best that I can be, but also provided guidance and support when I needed it. I felt comfortable asking for help from anyone, and that speaks to the type of learning environment at Novartis.
Finally, the soft skills I learned and honed during my fellowship also helped ease the transition to an industry professional. I developed some soft skills in pharmacy school, but definitely grew leaps and bounds during the fellowship, as the pharmaceutical industry is vastly different environment. The soft skills that play a significant role in my current position include teamwork, communication, time management, and adaptability.
As an ACS, teamwork is a huge part since we work with team members from all different functional areas to reach a common goal of successfully completing the study. Many of our teams are global, so communication is very important; we are in constant contact with team members via email, phone call, instant message, or face-to-face. Because we have colleagues on the other side of the world, scheduling calls with them can sometimes be a challenge. I try to be cognizant of the time differences and schedule meetings with them during a time that works best for all, but sometimes that means coming into work an hour earlier, or staying a couple hours later. Time management also comes into play when I am trying to juggle several urgent tasks across multiple studies. I thought my time management skills were sufficient in pharmacy school, but time management is so different in my role now. My action can have a downstream effect on my study team, the clinical sites, and even patients, so I have had to learn how to better prioritize my activities depending on the severity of the urgency.
As I am continuing to learn, there are always obstacles in managing early phase clinical trials. The best way to cope with these challenges is to be flexible and adapt to whatever difficulty comes my way. Because safety is almost always a key endpoint in our studies, we do not want to sacrifice their quality. This sometimes means we have to extend our timelines or ask for more financial support so that we can answer a specific study endpoint, and our teams have to adapt to these changes accordingly. In order to have a collaborative team and run a successful study, communication, time management, and adaptability are all equally important aspects. These skills that I developed in the fellowship and continue to utilize now as an ACS are not only specific to clinical operations, but are highly transferable to any career.
Amanda Nguyen, PharmD, is an alumna of the MCPHS University/Novartis Clinical Sciences & Innovation Fellowship Program and currently is an Associate Clinical Scientist at the Novartis Institutes for BioMedical Research