Lauren Neighbours Wilcoxen, PhD, is the SVP of Product Development and Regulatory Affairs for clinical-stage oncology biotechnology company, Checkpoint Therapeutics. Dr. Wilcoxen led the submission of Checkpoint’s first marketing application for a novel cancer immunotherapy, UNLOXCYT, which was approved by FDA in December 2024 for the treatment of adult patients with advanced cutaneous squamous cell carcinoma. In addition to leading regulatory strategy and operations at Checkpoint, she is responsible for oversight of the clinical, chemistry, manufacturing, and controls (CMC), and supply chain functions for the company. Dr. Wilcoxen’s areas of expertise include biotechnology, healthcare, oncology, immunotherapy, and executive leadership.
Recently, in an exclusive interview with CXO Outlook Magazine, Lauren shared her professional trajectory, insights on the importance of diversity and inclusion in the workplace, the secret mantra behind her success, future plans, pearls of wisdom, and much more. The following excerpts are taken from the interview.
Hi Lauren. What inspired you to pursue a career in regulatory affairs, and what motivates you to continue in this field?
When I first started college, I was a pre-med Biology major pursuing a future career in medicine. My freshman Biology teacher offered me a part-time paid position to do undergraduate research in his laboratory, which turned out to be a life-changing moment for me as I enjoyed working in the lab and running my own experiments. That experience led me to pursue my PhD in Microbiology and Immunology where I did 4.5 years of laboratory research to earn my degree, including several years in a biocontainment facility. I decided towards the end of graduate school that a life at the bench wasn’t for me, and that I’d prefer a career that brought me closer to my original goal of treating patients. That decision, along with a series of career fairs, informational interviews, and countless hours of research, led me to apply for a job in clinical research that involved not only clinical operations but also regulatory affairs strategy and program management.
While my introduction to regulatory affairs was a bit of a happy accident, I’ve been involved in regulatory affairs ever since, while also taking on leadership roles in other functional areas. What I enjoy most about regulatory affairs is that it gives you an umbrella view into a drug development program. A solid regulatory affairs strategy should be built at the beginning of a drug development program, developed to target your end goal (such as marketing approval), and updated throughout the program to accommodate the shifts and changes that occur with time. Being a regulatory affairs executive is similar to being a parent – I get a front row seat in shepherding a drug development program from its infancy through the rough teenage years and hopefully into successful adulthood where it can benefit society at large. Seeing your “baby” thrive and help others in the process is an incredibly fulfilling experience.
What do you love the most about your current role?
I am incredibly blessed to get paid to do a job I thoroughly enjoy. I love leading a talented and motivated team of people who are committed to our mission to revolutionize cancer therapy. And I love waking up every day to tackle a new set of challenges. Leading our small but mighty Checkpoint team to our first marketing approval was an incredible adventure, and I’m excited for the next phase of this journey.
How do you see the regulatory affairs profession evolving in the next 5-10 years, and what skills or knowledge do you think will be essential for success in this field?
My approach to regulatory affairs as a holistic and overarching product development discipline was shaped by my earliest experience in the field. While this view has been adopted by some organizations, particularly smaller biotechnology companies and start-ups, many often still view regulatory affairs as a siloed compliance-focused organization built upon red tape. Compliance is essential to the function, but it is just one element of a more complex regulatory affairs strategy for a program. Regulatory affairs leaders should be encouraged to think outside the box, take calculated risks and push boundaries when appropriate to achieve the best strategy for all stakeholders. The most effective regulatory affairs leaders are also those who understand the needs and priorities for all other functions in the organization and keep all stakeholders in mind when executing on the product development strategy.
I anticipate more organizations will adopt a more complete view of the regulatory affairs function in the coming years and focus their hiring efforts on identifying individuals who not only have the technical expertise to do the job but also the breadth of cross-functional experience needed to be most effective long term in the role.
Recently, you were recognized as one the Top 50 Women Leaders in Healthcare for 2025. Our readers would love to know the secret mantra behind your success.
If there was a secret mantra, I’d gladly share it! I’ve always been goal oriented and mission driven, which has led me to push myself beyond my comfort zone professionally and personally to achieve my ambitions. I grew up with a family who constantly told me and my siblings that you can do anything you put your mind to, and you can be anyone you want to be. I’m very aware that my success is a direct reflection of my team’s hard work and my incredible support system, so I also lead my life and my team with empathy and gratitude.
What are your thoughts on diversity and inclusion in your field? How important is it to have authentic conversations with leaders, professionals, and changemakers to create more acceptance across the globe?
There’s been extensive research into the benefits of diversity, equity, and inclusion (DEI) in many fields, including healthcare, and almost universally, these studies have shown the benefits of DEI in the workplace. Fostering a positive work culture that values DEI leads to numerous advantages including but not limited to attracting and retaining more diverse talent, developing more creative and innovative strategies, and improving company decisionmaking because the decisionmakers are more representative of the customers / patients / stakeholders who are impacted by those decisions. It’s important that the long-term goals and benefits of DEI do not get lost among everchanging day-to-day societal and political views because the evidence supporting the benefits of DEI efforts speak for themselves.
If you could have a one-hour meeting with someone famous who is alive, who would it be and why?
Such a tough question! My frustratingly honest answer is, “it depends,” because the person I’d want to speak to most today may be different than the person I’d choose tomorrow. Today, my choice would probably be Mel Robbins because I love her sincere and candid approach to delivering simple yet effective advice, and I think I’d come out of that meeting with Mel feeling inspired. Although if I’m in the mood for a good laugh, I’d choose Ryan Reynolds because he’s hilarious and would probably pick a great lunch spot for an hour-long meeting.
Is there a particular person you are grateful for who helped get you to where you are?
It’s impossible to pick one person. My parents and siblings have always been my cheerleaders, and I’m eternally grateful to them for their love and support. My kids make me a better human, and they teach me lessons every day that help me at work and at home. My husband is my best friend and my biggest fan, and he has encouraged me to embrace my voice and pursue my ambitions. And I’ve benefitted from a professional community of coworkers, mentors, and leaders throughout my career who’ve had a profound influence on me.
How do you keep your mind healthy and stay resilient? And how do you motivate your team?
I have an overactive brain, and I need intellectual stimulation inside and outside of work to stay healthy. I like to read and listen to audiobooks, where I regularly alternate between nonfiction and fiction, and I read the news daily from a variety of news sources to stay up to date on current events. I also love to travel and experience different cultures, which is both enriching and helps me keep things in perspective. At work, I want to do well for my team, and for the patients who may one day benefit from the therapies we work on. On days that are tough, I focus on our mission and decide to show up and do the best I can that day. I make an effort to regularly show appreciation to my incredible team, and I also remind them of my “why” – our patients – which motivates us to work together towards a common goal.
What do you hope to achieve in the next 5-10 years, and how do you plan to get there?
I want to continue working in the biotech field contributing to the development of new and improved treatments for patients who need them. I intend to do so both as a biotech executive and through taking on more board roles to contribute to the governance and success of other companies in the field as well.
What advice would you give to someone just starting their career in regulatory affairs?
Empower yourself through knowledge. Seek out opportunities to learn more about different companies with regulatory affairs roles through career fairs, informational interviews, free or paid courses and seminars, etc. Identify people in the field who mirror the kind of career you want to have, and reach out to connect with them on LinkedIn, or via a mutual connection. Involve yourself in local regulatory affairs professional groups, conferences, and networking events. And be open to new opportunities as your ultimate path to success may not be a straight line.