“[Enrolling in the Certificate Program in Clinical Research Conduct and Management] was probably the best decision I've made in my life—I am not exaggerating. I have my current job literally because of this certificate program,” says Kevin Chen, now a consultant medical writer at Agios Pharmaceuticals. Not knowing what to expect when he enrolled, he now reports, “I would not be where I am today had I not taken these courses and met all these amazing people.”
Looking back, Kevin would never have predicted this career outcome. When he was freshly out of college with a biology undergraduate degree, Kevin “had barely the vaguest notions of [his] future.”
I feel as though anything can happen, and I am at peace with the healthy balance of uncertainty and control I have for my future, which is in such stark contrast to my outlook on life prior to enrolling at UC Berkeley Extension.
His job-application frenzy ensued, submitting more than 100 applications through government and corporate job sites in the following months. But it was not until he connected with a recruiting agency in February 2015 that Kevin found work as an oncology lab researcher at Bristol-Myers Squibb.
At the same time, a relative who worked as a pharmacovigilance director at Genentech recommended that Kevin take a regulatory affairs/trial management class to learn more about clinical science. Not familiar with either subject, he picked our Certificate Program in Clinical Research Conduct and Management because it sounded more interesting than regulatory affairs.
He made this decision on something of a whim, and it turned out to be a life changer: Kevin found himself inadvertently networking with instructor Marianna Lenoci, who then connected him with a hiring opportunity.
“I had mentioned to Marianna in passing—with no indication I was looking for new opportunities—that I had picked up some scientific writing experience from one of my coworkers at Bristol-Myers Squibb,” Kevin recalls. “A week later, Marianna told me that one of the upcoming instructors, Karen A. Henry, was looking for a new medical writing intern. I said I was very interested, so Marianna connected me with Karen. I joined Karen’s company, Dynavax, in December 2015.
“From that point on, it seemed as though doors were opening all around me,” continues Kevin. “At Dynavax, I was not only introduced to medical writing, but I was also allowed to rotate into other pharmaceutical departments, such as clinical operations, drug safety, medical affairs, commercial launch and project management, because Karen believed that I had sufficient breadth of knowledge from taking her classes.
“It seemed as if I could go in any direction I wanted, and the little I knew of each department enabled me to ask poignant questions of the brightest minds in the industry, people whom I never thought I would interact with,” marvels Kevin.
That internship not only helped Kevin to learn and grow, but also established him as a medical writer. “I became a full-fledged medical writer when I joined another pharma company, Exelixis, in October 2016. I worked at Exelixis for two years until I returned to Dynavax in December 2018, and after an unfortunate company-wide layoff of all Dynavax oncology employees, I landed my first consulting role at Agios Pharmaceuticals.”
Kevin offers additional thoughts on his educational experience.
On his classes:
They illuminated an entire industry and a collection of professional fields I would never have learned about otherwise. The subject matter is intrinsically dry—like law—but the instructors really gave the classes life. They are active professionals in the industry and engaged us with practical scenarios that we couldn’t envision just by studying the regulations.
On his instructors:
(2018 honored instructor) Marianna Lenoci and advisory board member Karen A. Henry, in particular, gave us an appreciation of why there are so many controls in pharmaceutical regulation and what can happen—and has happened—if those controls did not exist.
Their teaching materials were based on the fundamental principles of patient safety, human rights and scientific integrity, and that really struck a chord with me.
Another instructor, Siu Po Sit, had incredible classes on study design, and I still apply his teachings to this day.
My project management instructor, Kathleen (Kay) Monroe, also had fun classes on managing critical paths, leading teams of people who do not report to you, and fostering collaboration and positive energy.
These teachings weren't just transferable to professional life; I apply these to my personal life, as well.
On how to best succeed in the certificate:
Open yourself up as much as possible. Don't be afraid to ask every question that comes to mind because the material is not common knowledge. Introduce yourself to everyone you meet because you will learn as much from them as you will from your instructors. I am still good friends with one of my classmates and even worked with her while I was at Exelixis. Do not take for granted the value of each connection you make, because there are amazing people in every corner of the world disguised as just faces in the crowd.
With the bedrock philosophy that you get from this program—that you should prioritize patient safety, human rights and the integrity of scientific data—you can shape the industry for the better. In all pharmaceutical companies, there are thousands of opportunities for improvement, especially because a surprising majority of the current workforce has no prior scientific or technological background.
If you are looking for a career change and are interested in pharma, health care, human rights or clinical science, I would recommend this program.
With the bedrock philosophy that you get from this program—that you should prioritize patient safety, human rights and the integrity of scientific data—you can shape the industry for the better.
If you are already in pharma and would like to progress your career by learning the purpose of your work or understanding the big picture your role plays in health care, I would recommend this program.
On his future:
I have always had entrepreneurial interests, and after my experiences in pharma I could entertain projects in health and social welfare. I also have to consider the possibility of being a husband and a father, so I may opt for stability and continue to progress as a medical writer or in some other biotech profession.
I feel as though anything can happen, and I am at peace with the healthy balance of uncertainty and control I have for my future, which is in such stark contrast to my outlook on life prior to enrolling at UC Berkeley Extension.
On the future of this field:
My biggest takeaway from this program was that the future of this industry is essentially in our hands. Biotech Bay (the organizations that comprise biotechnology, pharmaceutical and medical device industries in San Francisco and Northern California) is a small world where I have seen the same faces over and over, across different companies and conferences.
Looking back, I believe I made an impact, however small, on the lives of patients that would not have been possible if it were not for my enrolling in the Certificate Program in Clinical Research Conduct and Management.
This leads me to believe that any one person can leave a big imprint on how our industry functions. So if I can come up with a more efficient way to track the status of all our hospitals and manufacturers, maybe I can save $1 million and cut a year off our timelines without cutting corners, which would lead to delivering pharmaceuticals to patients faster.
Or if I can persuade the vice president of the company not to overlook a certain regulation, maybe I can reduce the risk that a patient will get hurt in our study.
Looking back, I believe I made an impact, however small, on the lives of patients that would not have been possible if it were not for my enrolling in the Certificate Program in Clinical Research Conduct and Management. I have the conviction that the work I am producing is helping society take a positive step forward. And as extra credit, through hard work and camaraderie, I have made friends in the most surprising places.
I can say with confidence that I owe a large part of my success thus far to the foundation of knowledge and wisdom I acquired through the certificate program.
