As Principal Professional at LEO Pharma, Karina Nymark ensures that trials are run according to all elementary principles. Her role is also to drive the clinical trial team forward and, perhaps most importantly, to safeguard patient safety and integrity.
Tell me, what are the daily life and work tasks of a Principal Professional?
“It is up to me to ensure that the trial is running according to protocol, GCP rules and regulations, and that the safety and integrity of the patients are secured during the trial. It is also my job to ensure that the whole team of experts involved are working well together, that the timeline and quality live up to the standards and that all CRAs have the best knowledge available to assist the site in doing the best work possible. I also ensure the quality of data and look for trends to see if anything stands out, so that any divergence is discovered as early as possible.”
Are there any ethical issues or dilemmas that you encounter in your work?
“Absolutely. For example, occasionally a patient is involved in a trial who shouldn’t have been enrolled. This is not always discovered right away and sometimes the patient has received treatment and is even getting better. What do you do then? Do you take the patient out of the trial? Some companies have a policy for these cases, but often you need to discuss that specific situation with the trial team and reach a decision together. I was once working on a trial for major depressive disorder where patients were actually suicidal. Here I really found that if people were getting better during the trial I couldn’t take them out of it. Whatever you decide, you need to document your decision carefully. In the end, I’m in this game because of the patients. They always come first. My main focus is to ensure patient safety and integrity during the trial and that investigators follow the protocol carefully in order for us to obtain quality data.”
What would you say is most challenging with your job?
“Ensuring that everybody gets the right information at the right time, which includes internal as well as external stakeholders. It can be a challenge to see to it that we are all running in the same direction and at the same time making sure that we are sticking to the timelines, quality and budget. Of course, you can’t always achieve them all. Sometimes we can’t exceed the budget but agree on a quality that is acceptable. Other times quality is the most important factor and something needs to be delayed. In these types of situations I need to make sure that everyone agrees and that we are making the right decision at that point. During two current phase III trials I’ll be working closely with a colleague. This is of great value to me as we share the responsibility and split the tasks between us. It gives us the opportunity to discuss the issues and that gives us a better possibility to see things from different perspectives and in that way we end up with better solutions and we are able to take the right decisions. Overall, building a network of friends and associates that I can discuss issues with has been very helpful. I have come to know a lot of people over the years and always have a friend to call, which is extremely valuable.”
And what is most fun?
“I really enjoy all of the challenges in this job. No two days are the same and new questions always arise during the day. It can of course also be a bit frustrating sometimes, when you have made plans in the morning and then the day ends up in something totally different. But it means that you need to be very flexible and be able to keep calm in stressed situations, otherwise you’ll burn out quickly. Another important factor that I really enjoy is getting people to work together to reach a common goal.”
What trials are you involved in right now?
“I am currently involved in two phase III global trials that will include more than 1 500 patients with atopic dermatitis. I will be one of the trial managers for these two studies that are based on the results of a phase 2b clinical study for tralokinumab in adult patients with moderate to severe atopic dermatitis. Tralokinumab is an investigational monoclonal antibody that specifically targets the cytokine IL-131, which plays an important role in the development of moderate-to-severe atopic dermatitis. The study showed some positive promising results when it comes to blocking IL-13 signaling. Studying tralokinumab further could tell us more about how you could not only treat atopic dermatitis with symptomatic treatment but actually reach a level where you stop the disease from breaking out.”
How long have you been working as a Principal Professional and what did you do before your position at LEO Pharma?
“I have only been with LEO Pharma since the first of February this year, but I have spent the past ten years in trial management and my career in life science dates back to the middle of the 1990s. I had just started my study for a Masters degree in pharmacy in 1996 when I started working as a student assistant in clinical trial supply at Lundbeck, where I stayed for five years. Then followed a couple of years of finalizing my Masters degree and working at a pharmacy. I always knew I wanted to go back to the pharmaceutical industry. In 2004 I got the chance to work with clinical trial supply again and later I moved into clinical operations. I was contacted by a friend from school who asked if I wanted to work as a CRA, which sounded like a great opportunity. I did that for a year and then returned to Lundbeck, this time as a trial manager. In the years that followed, I had trial management positions at Ferring, Takeda and in small biotech firms, as well as a PM role in a CRO, before finally starting here at LEO Pharma.”
Do you have any advice for those who are thinking about a similar career choice? Are there any specific qualities or strategies that can be good to have?
“In this job you need to maintain the overview of the work that is carried out and also be able to manage people. A diplomatic approach is important, as there are a lot of stakeholders involved on various levels and you need to be able to collaborate with all of them. Carrying out clinical trials is a lot about team performance. That’s why you need drive and the ability to motivate others in the role as trial manager. I have taken a number of management courses and learnt much about motivation, something that could be a good thing to invest in.”
What was it that drove you to work with clinical trials from the beginning?
“When I was younger I thought about if I could do something with my life, what would it be? I felt very strongly that I wanted to make a difference for people. I believe that by carrying out clinical trials we do make a difference for patients. When you think of atopic dermatitis you might think that it can’t be that bad. It’s not a ‘hot’ disease like cancer. But atopic dermatitis is an illness that has a huge impact on people’s lives. They don’t sleep well at night, the skin becomes red, swollen and cracked and extremely itchy, and that can lead to hours of scratching. As a skin disease it can also affect self-esteem and relationships. Some patients have difficulties managing their job and might even have to give up on their career, which of course has an impact on their family life and economic situation. These people are desperate to find a solution. When it comes to eczema the main therapy tends to be symptomatic treatment. You put on a cream and hope that the eczema will go away. Often it does but sometimes that is not enough to help the patient. This is where I think that tralokinumab could make a difference and really be a life changer for people suffering from atopic dermatitis.”
If you hadn’t become a Principal Professional and worked with clinical trials, what would have been a possible career path?
“I often think about if I should move into project management, where you work on a more strategic level. That might be something I would like to do some day. But I can’t see myself not being deeply involved in the studies right now. I’m very passionate about my job and really enjoy working with clinical trials. So I’m not sure I would have done things differently either way. I like the background I have and the opportunity to work in trial supply, as well as a CRA, which provided me with a good platform as trial manager. It all led me to where I am today.”
Photo: Maia Soechting