When it comes to leadership in clinical trials today, what qualities are necessary to navigate the evolving landscape of clinical research effectively? Christine Enciso, Vice President of Development Services and Operational Excellence at Regeneron, brings over 28 years of clinical research expertise, establishing herself as a distinguished figure in navigating the challenges of leadership within this dynamic field.
Xtalks recently had the opportunity to discuss Enciso’s journey in the clinical research industry and her decision to join Regeneron. During the conversation, she elaborated on the significant challenges within her role, how she overcomes them and her predictions for the future adaptations needed in the clinical trials landscape.
Continue reading to explore effective leadership in clinical trials. For insights on addressing leadership-related obstacles in clinical operations, join Enciso and other esteemed professionals in the field by participating in our upcoming Xtalks Clinical Trial Leadership Peer Circle.
Can you begin by telling us about your experience in clinical research?
Christine Enciso: My journey in clinical research spans over 28 years, mainly focused on clinical trial operations. It all began at Upjohn in Kalamazoo, Michigan, where I started as a Statistical Programmer. I came into this field, as many did back then, discovering my passion for data along the way.
Through mergers and acquisitions, such as the one with Pharmacia, and later Warner-Lambert and Pfizer, I navigated transitions, gaining valuable experience. This led me from data management to study, program and asset management, each role expanding my technical and leadership skills. As I became adept at integrations and operating models, my focus shifted to relationship and alliance management. Over my last 10 years at Pfizer, I sharpened my skills in collaborating with external providers and enhancing clinical trial execution.
My career has been a progression of roles, continually expanding in scope and leadership, culminating in a focus on operational excellence.
What prompted you to join Regeneron?
Christine Enciso: Why did I choose to join Regeneron after a 23-year career at Pfizer? Well, after spending so much time in one organization, there comes a point where you realize that to truly reach your potential as a leader, you need to step outside of your comfort zone. While I had built strong relationships and achieved success in my previous role, I felt a desire to challenge myself further and explore new opportunities.
Several factors led me to Regeneron. Firstly, the chance to work in a different area of medicine, focusing on antibodies and genetic medicines, intrigued me. It offered a fresh perspective and the opportunity to expand my knowledge base. Additionally, the mid-size, smaller biotech environment presented a new set of challenges and opportunities that I found appealing.
What ultimately sealed the deal for me was the prospect of learning and developing as a leader in a new setting. I knew that by making this move, I would be able to apply my expertise while also gaining valuable experience in a different organizational context.
Since joining Regeneron, I’ve had the opportunity to take on various responsibilities and expand my role significantly. From vendor relationship management to overseeing multiple functions supporting global development, each new challenge has allowed me to further hone my leadership skills and contribute to the company’s success.
In particular, my focus on operational excellence has allowed me to leverage data-driven insights to improve efficiency and drive continuous improvement initiatives across the organization. It’s been an incredibly rewarding experience, and I’m excited to continue making a meaningful impact at Regeneron.
XTALKS PEER CIRCLE: Clinical Trial Leadership Peer Circle – Group 2
Members of this Peer Circle will gain access to other leaders in clinical operations and form a mini think tank to help solve pressing issues that they are facing in managing trials.
What is your biggest challenge in your role as the Vice President of Development Services and Operational Excellence at Regeneron, and how do you manage it?
Christine Enciso: My biggest challenge as the head of a shared service function is continuously seeking out optimized and efficient ways to support the business. As an infrastructure group, we don’t scale our headcount in the same way as other portfolio-based lines of business. This means we must relentlessly focus on process improvements and automation to absorb a growing workload and enable the rest of the organization to operate effectively. Balancing the need to drive efficiency while maintaining high service levels for our internal partners is an ongoing challenge that requires constant attention, innovation and change management.
To manage this, I rely on my exceptionally capable and experienced leadership team and strong administrative support. I prioritize self-care to handle the stress and pressure that come with the role. Additionally, I focus on fostering productive interactions and relationships within the organization to maximize efficiency and recharge my energy. Having a supportive manager who helps prioritize and provides perspective on the bigger picture is also valuable.
You’re the chairperson of our new upcoming Clinical Trial Leadership Peer Circle. What qualities do you believe define true leadership in clinical trials?
Christine Enciso: In my view, a distinguished leader in clinical trials is an individual who not only possesses firsthand experience and pertinent expertise in the field, but also can inspire, motivate and develop others to reach their highest potential. This leader effectively translates knowledge, while remaining cognizant of the dynamic challenges that arise, including regulatory shifts and technological progressions. They persistently pursue new knowledge, adapt to changes and implement innovative solutions.
“I’m a hands-on learner, so my style is see, do, teach, lead. That’s my way of doing things.”
— Christine Enciso
An exemplary leader is one who comprehends the intricacies of the business, draws wisdom from previous experiences and maintains a forward-looking perspective. They are not just focused on their own growth, but also on the development of their team, striving for collective enhancement and growth. Their leadership style fosters an environment of inspiration and motivation, encouraging each member to unlock their full potential.
What do you anticipate will be the next big challenge in clinical trials? How can Clinical Operations professionals prepare for it?
Christine Enciso: The emergence of AI presents numerous challenges and opportunities in clinical operations, such as enhancing patient recruitment by analyzing electronic health records for potential trial participants, optimizing trial design through the identification of relevant endpoints and prediction of potential challenges, and improving monitoring and safety by enabling real-time tracking of patient safety and treatment efficacy. Preparing for this shift involves understanding the ethical, transparent and unbiased integration of AI into clinical trial operations. This requires learning, listening and comprehensively assessing AI’s capabilities and limitations. Moreover, professionals must develop new technical skills in AI, machine learning, automation and data sciences to support this transition effectively.
Christine Enciso, Chairperson of the Xtalks Clinical Trials Leadership Peer Circle, will use her expertise to guide discussions throughout the six-meeting program. Discover how you can engage in this exclusive networking opportunity.
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