Clinical Operations: Jeff Cehelsky

Jeffrey E. Cehelsky, R.Ph., M.B.A. is the Senior Director of Clinical Operations for Alnylam Pharmaceuticals in Cambridge, MA.

How did you choose your career? Was this an easy or hard process for you? If you struggled, how did you overcome these struggles?

When choosing my original career path, I had no idea I would end up in clinical operations. I knew that I wanted to be involved in the healthcare and science industries, without becoming a physician, so I chose Pharmacy (at University of Rhode Island) as my original career. It wasn’t until I went back to graduate school that my career path in clinical development took form.

After working as a hospital pharmacist, I went on to get my M.B.A. with a focus in Marketing from Boston College and started to research opportunities with the healthcare industry — such as hospital administration and pharmaceutical sales. However, during my tenure at the hospital pharmacy I began to notice the larger number of clinical trials being held and that clinical development was becoming a growing industry in Cambridge, MA.

What was the process like to apply for your first job after your training was over? Was it easy or difficult? How did you cope with any difficulties? Did that differ from subsequent jobs you’ve had?

Initially, it was difficult finding a position within pharmaceutical and biotech companies, so my first job was for a clinical research organization (CRO, consultant groups that work with large pharma companies, medical device companies, and biotechnology companies to help develop and execute clinical research plans). It was actually a great way to learn the industry first-hand, at an accelerated rate, leading to numerous career experiences.

What advice would you give to someone interested in following a similar career path?

There are very few degrees offered in Clinical Operations — Northeastern now has a graduate certificate program in Clinical Trial Design and Program Management. And originally, the field grew out of nursing professionals wanting to work in the industry, but these days companies are more open to look at candidates with a background in science (biology or chemistry). Additionally, if you are working at a company as a scientist (or at the "bench") more than likely there may be an opportunity for you to “cross-train” as part of the company’s internal career development program. To gain basic knowledge about the field, industry chapters like the Massachusetts Biotechnology Council offers semester-long evening courses on Clinical Research and Drug Development.

How do you achieve career-life balance? Is this easy or hard to do? How many hours do you typically work per week?

Work-life balance, I believe, is an individual process. It’s difficult with technology allowing for a 24/7 connection; for me, I’ve set up “check-in” times — in the morning and the evening and based on priority and urgency — I’ll chose how to respond. It is necessary for me to have these check-in times because we are running clinical trials in a number of different countries and time zones, many times it’s just status reports and checking in keeps the ball rolling, and then there are times that something is urgent and needs to be addressed. The other thing I would add is that you, as an employee, need to be both flexible but also set expectations with your superiors, employees, and peers.

What strategies have you figured out over time to help you succeed?

That it is a team effort. As you begin growing in your career, you’ll think you should do all the work (of course, sometimes you have to due to the size of the company or your team), but there will come a time where you will have to delegate and share responsibilities. This isn’t just to get the work done, but so that you can grow (both in your position and as a leader), nor is it a way to shirk off responsibility. Which leads me to my next point: what I do, what we do, managing and developing clinical trials, is a team effort and it’s important to assemble the best team possible. I don’t necessarily mean smartest but rather the best people and right personalities that extend beyond employees and includes consultants and contractors. One should not take it lightly or for granted that if you hire a top notch CRO or consultant, that you’ll be assigned the right person. Instead hand pick them and check the team members' individual references before you say yes. Lastly, one should always lead by example, and demand of yourself what you strive to achieve with your team.

How do you see your field changing in the next 5–10 years?

Clinical development of new therapeutics can no longer be done in a single country. The need for clinical development takes these products around the globe. I expect that the demands from specialized patient populations and the treatment of naïve patients will further expand the need for clinical trials into new countries. In doing so, trial timelines will become extended as a result of multiple country regulatory submissions.