What can you do with that PhD? 🤷♂️ Chapter #3
Interview with Andrew, a Molecular Biologist who transitioned to become a Clinical Scientist in the pharmaceutical industry.
Andrew's background is deeply rooted in science, having previously engaged in extensive bench work and wet lab experimentation. Now, he delves into the intricacies of designing clinical studies, particularly in Phase 1 and 2 trials. As the key architect of these studies, he meticulously designs study protocols, often crafting intricate flowcharts to guide the study's trajectory.
I recently had the opportunity to connect with Andrew to gain insight into the role of a Clinical Scientist in the pharmaceutical industry. Andrew's background is deeply rooted in science, having previously engaged in extensive bench work and wet lab experimentation. Throughout his PhD, he delved into preclinical models of hepatocellular carcinoma, concentrating on a particular gene and employing knockout models. Subsequently, during his postdoctoral research, he shifted his focus to studying DNA damage primarily utilizing in vitro and organoid models.
Upon transitioning to the industry, he initially joined a small biotech company, which was later acquired by a larger pharmaceutical corporation just two years into his tenure. This acquisition thrust him into the complex realm of restructuring, where he found himself navigating changes not only to his role but also to his team dynamics.
He mentioned that “transitioning from a modestly funded biotech to a large pharmaceutical company with ample financial resources was both remarkable and, truth be told, fortunate. Additionally, the advantage of being able to remain in my city without the necessity of relocating and enjoying a fully remote work arrangement, even before the onset of COVID-19 was an incredibly favorable arrangement!"
Within the pharmaceutical landscape, Andrew's focus lies specifically in oncology, primarily within the realm of clinical development—a facet distinct from clinical trials, as it involves more strategic planning rather than operational execution.
In his daily responsibilities, Andrew delves into the intricacies of designing clinical studies, particularly in Phase 1 and 2 trials. Phase 1 primarily centers around ensuring the safety of the investigational product, while Phase 2 delves deeper into establishing proof of concept. As the key architect of these studies, Andrew meticulously designs study protocols, often crafting intricate flowcharts to guide the study's trajectory.
“To be fully honest with you, any PhD scientist with a background in biology can shift into clinical science. While it may seem daunting, considering the complexity of my postdoctoral training, it's just a matter of becoming acquainted with the terminology utilized in clinical trials.” He says.
Tailoring Study Design, Strategic Recruitment, and Collaborative Partnerships
Beyond the theoretical framework, Andrew's day-to-day involves a hands-on approach, where he meticulously examines various factors such as patient demographics, dosing regimens, and measurement characteristics to tailor the study design accordingly. He strategically selects patient cohorts based on their potential efficacy and adjusts recruitment strategies to optimize trial outcomes. This often involves striking a delicate balance between accelerating recruitment efforts and pausing to allow for comprehensive data analysis.
Collaboration is integral to Andrew's role, as he frequently liaises with Contract Research Organizations (CROs) to refine trial protocols, do quality control, and ensure alignment with regulatory standards. Additionally, he engages in predictive analytics to anticipate pharmacokinetic outcomes and identify suitable patient populations, all while managing the legal aspects of trial contracts.
Moreover, Andrew is actively involved in the evaluation and selection of potential collaborators, organizing meetings and documenting discussions to facilitate informed decision-making. Furthermore, he proactively identifies and addresses potential risks to the study through comprehensive risk registers, proposing mitigation strategies to preemptively tackle future challenges.
In essence, Andrew's role as a clinical scientist encompasses a diverse array of responsibilities, ranging from strategic study design and patient cohort selection to collaborative partnerships with several stakeholders and risk management. Through his multifaceted approach, he plays a pivotal role in advancing oncology research and driving innovation within the pharmaceutical industry.
For aspiring PhDs and postdocs aiming to transition into industry professionals within Clinical Science, Andrew suggests exploring additional tools and advice available in the paid version detailed below:
Clinical trial research may require a different skill set than academia, so be willing to adapt and learn new methodologies, regulations, and processes…