Creating Hope and Changing Lives

York alumnus and York Adjunct Lecturer Nizam Talukdar (2013) working on life-saving drugs.

Discovering a career in clinical research management turned out to be a fortunate turn of events for Nizam Talukdar. While working as a laboratory assistant processing samples at The New York Blood Center, he stumbled on a posting for a clinical research assistant position and applied. He landed the job, and his career dreams shifted: he saw the opportunities in this new field—from working in private practices to hospital settings and pharmaceutical companies.

What was it like when you started in the field?

My first clinical research position was at a dermatology practice in Manhattan, where they also conducted studies. One of my first studies was for Botox, which had 40 subjects. As the clinical research assistant I scheduled participants, measured blood pressure, and did the EKG. Following those tests, I would bring in the investigator who completed investigative documents. When I worked on an acne study, it involved distributing medication to 20 patients and accurately tracking the number of pills they received and returned. Since the pharmaceutical company was not on site, we collected data on their behalf. They would review and cross-check our information for any errors. Starting my career with smaller studies helped me master the skills necessary to move up. I was promoted to Clinical Research Coordinator and later Lead Clinical Research Coordinator. That position was good preparation for the work I do today.

When you became a Regulatory and Data Specialist at Cornell Medical College, how was that experience different?

Cornell was my first experience in oncology, and oncology is a different beast. The studies were still small, but the work was more intense. Some only had three subjects, others had ten patients, and one biomarker screening trial I worked on had 50 participants. It was my first time working with chemotherapeutic drugs, and I needed to understand the science behind them. Although I wasn't an expert, I had to be able to explain how the drugs and procedure worked for the patients. The study processes were also more labor intensive. There were more blood draws, CT scans, and other screenings. Cornell had multiple departments that handled those tests, but I needed to coordinate all patient schedules and be present at the appointments to collect data points.

I think one of the most rewarding aspects of my work is knowing that I am making life-saving drugs. Sometimes it's challenging to visualize what I'm working towards in my current position, because I don't work directly with the patients or understand their reasons for participating in the trial. They are numbers on a spreadsheet. But getting FDA approval and seeing patient's positive feedback really gives me joy and purpose—especially knowing how much time and work has gone into obtaining these results.

Your first position at a pharmaceutical company was with Lupin as an Associate Project Manager, where you worked on studies for asthma-related medications. What were the benefits of working at a smaller company?

At a smaller company, you get to wear different hats. Lupin manufactured generic drugs, and the investigational drug studies I worked on had 30-50 healthy volunteers. It was a nice introduction to working on the pharmaceutical side of the business. One of the benefits of working on a smaller team is you get to utilize your knowledge of all areas of clinical trials. As a Clinical Trial Manager you also drive the project, and it's easier for your accomplishments to stand out. You move up through the ranks more quickly in this kind of environment.

What was your learning curve moving to a big pharmaceutical company like Johnson & Johnson?

There are some great benefits to working in Big Pharma. The companies are well funded, so the salaries are higher and the benefits are better. The environment is fascinating because they are the ones who are working with the most complex and life-changing medications. However, because the companies are massive, individual roles are siloed. The benefit is you get to specialize and hone your skills in a specific area.

But even when you start in a senior role at a company like Johnson & Johnson, there are at least two to three months of training. Every company has its SOPs (standard operating procedures) and regulatory practices that you need to learn. The good news is there are also a lot of resources to help, including guidance documents and experienced team members.

What are you working on now?

Right now, I am working on bladder cancer drugs, overseeing trials in 20 countries in North America, South America, Europe, Asia, and Australia at over 200 hospitals and clinics. We usually work with one particular drug but may combine it with an already approved drug as a comparator or combination therapy.

Much of my day is focused on managing projects—from reading emails, to attending meetings and following up on specific aspects of the study with my teams in different countries. Critical thinking and comprehension of high-level scientific material are essential. But being organized is probably the most invaluable skill needed in this field.

Teaching has always been on my bucket list since I was an undergrad in biology at York. There was one particular class, biochemistry taught by Dr. Chang. It was such a complex class that we all studied together. The chemistry students would explain the chemistry side; the bio students clarified the biology side. So, that was a lot of fun. And I always offered to tutor my classmates. When I had an opportunity to return as an instructor in the CTM program, I was excited; I enjoy engaging with the students.

But while I share my knowledge through teaching, I also get something back. Students challenge me with their questions. So, I am committed to increasing my knowledge in whatever subject I teach. I go back and do new research. As a result, teaching has elevated my mastery of different aspects of my field. And it also honed my presentation skills, which benefits me personally and professionally.