In this series, we highlight specific functions or departments within typical pharmaceutical company organizations. We also feature the perspectives of women working in these different functions and their career journeys.
Introduction to the Clinical Science Function
The Clinical Science function is critically important for the clinical development of pharmaceutical products. Most noteworthy, this function is involved with every step of clinical trials, from the conception to the read-out, market approval filing, to publication. Thus, clinical scientists who work in the function play a major role in and have a big impact on clinical trials.
Clinical scientists work in a variety of settings, including large pharmaceutical or biotechnology companies and contract research organizations (CROs). In addition, academic research centers may also employ similar clinical scientist roles. In these places, they might write research protocols or administer them as clinical research coordinators.
About the Clinical Scientist Role
Clinical scientists are responsible for setting up and monitoring clinical trials. This involves collaborating with trial investigators and training the clinical trial sites. In addition, clinical scientists are responsible for writing clinical protocols, monitoring data, and reporting safety-related events. They work very closely with the internal physician who leads the trial (typically called the "study responsible physician").
At the end of the trial, clinical scientists may ensure that the clinical database contains all the data necessary for analyzing final outcomes to allow for decision making. First, they work with the biostaticians to get the data analyzed. Then, together with the rest of the clinical team, they help to prepare communications and regulatory documents submitted to the relevant health authorities.
Clinical scientists work on interventional clinical trials across different disease settings such as cancer, infectious disease, immunological diseases, cardiovascular disease, etc. In early-phase clinical trials, there may be one clinical scientist assigned to the trial. By contrast, for larger phase III clinical trials, there may be multiple clinical scientists working together on the same team.
Clinical Science Function Collaborates with Other Pharma Functions
In addition to interaction with the study responsible physician, clinical scientists also interact with professionals from other pharma functions. These include biomarker leads, safety scientists/physicians, project management, medical writers, statisticians, regulatory scientists, as well as other clinical trial leads and associates.
External to the pharma company, clinical scientists play a critical role in coordinating and communicating trial information to the investigators who advise on and recruit patients for clinical trials.
Education and Skills of Clinical Scientists
The educational backgrounds of clinical scientists can vary. Some have scientific backgrounds, with or without a PhD. Others may hold nursing degrees or have other clinical backgrounds and training. There is not one path to the clinical scientist role.
Clinical scientists must be skilled to have attention to detail. A large part of the role involves contributing to and reviewing regulatory documents. Therefore, it is important to minimize mistakes that can impact trials and timelines. Clinical trial monitoring may include reviewing data from the clinical trial database to ensure that data are up to date and that there are no inconsistencies.
Most importantly, clinical scientists need to have good communication skills. They communicate with both internal colleagues, like the study responsible physician, as well as external trial investigators. They may also communicate with those in many other internal functions as well as external vendors.
Function Feature:
Andressa Smith, PhD
Associate Director, Clinical Research, Janssen Clinical Development
1. Briefly describe your educational and professional background up to your current role.
I received my bachelor in Microbiology and doctorate in Molecular Biology. After graduating, I spent some years as a Research Fellow at the National Cancer Institute, focusing my research on Immuno-Oncology. After my fellowship, I joined Janssen in the Immuno-Oncology Discovery, and my current role within the company is in Clinical Research with the late-phase Clinical Development team.
2. Briefly describe your current role (responsibilities, day-to-day tasks, etc.).
I am currently responsible for several ongoing Phase 3 trials. My main tasks include medical monitoring, clinical trial oversight, and medical review of clinical trial data. In addition, I spend a lot of time writing and reviewing clinical-related documents. These include study protocols (this means spending a lot of time in designing studies, conception of primary and exploratory endpoints, etc.), clinical study reports, top-line results, Informed Consent Forms, training documents, preparation of scientific materials (manuscripts, posters, brochures, etc.), IND submission, and analysis of complex data for regulatory submissions and any other health authority filings.
3. What skills/attributes are needed for a candidate to excel in your function?
I think the ability to think critically and accept/provide constructive feedback are the most critical skills. But then again, these are essential skills to excel in anything in life, right?
4. What do you find most challenging about your current role?
I would say the complexity of running large phase 3 trials - which in turn requires a large team - can be challenging. Sometimes, decisions are not made as efficiently and timely as we all would like. It does take a lot of people to run clinical trials!
5. What do you know now that you wish you knew earlier in your career journey?
I wish I knew there were so many different career paths in industry, especially in big pharma. There’re so many roles that you/we can take on. You are never stuck, and I am lucky I can learn so many new exciting skills along the way.