Meet Stephanie Sheesley: Director, Regulatory & Access (USA)

"I love medical devices because no two devices are the same. The regulations aren't as black and white as for prescriptive drugs. I can creatively think about how I am going to write a submission to the FDA. "

Stephanie Sheesley works as a Director within Regulatory and Access leading a team and providing regulatory consulting for a variety of medical device clients. In this interview, Stephanie talks about her role, the projects she works on, and her passion for helping clients address unmet medical needs, such as spinal muscular atrophy and hearing loss. She also shares her thoughts on leadership and the importance of putting patients at the heart of everything they do, which is a key part of Parexel's brand promise, "We Care."

• Please introduce yourself and your role at Parexel.
  My name is Stephanie Sheesley and I’m a Director within Regulatory & Access based in south-central Pennsylvania. I support a team of 23 talented staff and as a Medical Device SME, I also have the privilege of providing regulatory consulting for a variety of Medical Device clients.
  
  
• What does a day in your job look like? What are your core responsibilities?
  Every day is different and I love it! A typical day consists of 1:1 meetings with staff, Leadership Team meetings, coordinating with our Global Resourcing Team to identify staff for incoming assignments, mentoring staff, and providing support to my Medical Device clients via meetings, submission support, or regulatory strategy. I also occasionally engage in new business development opportunities, which is also rewarding when we win the work!
  
  
• When did you join Parexel, and why did you choose Parexel?
  After nearly 14 years in a regulated industry, I joined Parexel in 2015 as a Manager with the vision of transitioning into the world of consulting to not only understand the business perspective but to also gain exposure to a variety of medical devices and pharma projects and to be there to help clients at their time of need. Every client is important, and every project is near and dear to their heart…so I enjoy being a part of their journey and being that reassuring voice that everything will work out. Parexel has such a vast pool of SMEs that we are literally a one-stop shop for clients.
  
  
• What would you like people to know about your job or department?
  In our Regulatory & Access team, we consist of a group of experienced, congenial staff who are willing to help not only our clients but go above and beyond at helping each other. Even though our teams are entirely remote, we have been able to utilize both technology and geographical opportunities to build interpersonal relationships. We are a small medical device team that covers all types of medical devices and we support submissions globally.
  
  
• What do you like most about the work you do in medical devices?
  I love medical devices because no two devices are the same. The regulations aren't as black and white as for prescriptive drugs. I'm also highly technical and very analytical, so it was a perfect fit for me. I can creatively think about how I am going to write a submission to the FDA. 
  Internally I provide regulatory fundamentals training for medical devices to home-grow our expertise in this area. It's open to anybody within the organization who is interested.
  
  
• Is there a project that had an impact on you?
  I worked on a project focused on spinal muscular atrophy (SMA), a genetic disease that affects a very small patient population. This disease is present at birth and can vary in severity. It is most common among Amish and Mennonite communities. I delved deeper into the topic since I live in South Central Pennsylvania, where I am in the heart of Amish country. I buy frequently from Armish-run farmers markets and I think they're just an amazing group of people which I like to support.
  
  The physician spearheading clinical trials for a combination device that was part of my project had been using the device off-label to treat his SMA patients. He collected data to support publications that would eventually support submission for FDA approval for the device. The Amish were receptive to being treated by him to acquire a potential treatment option for SMA that is less invasive than the current one. I was proud to contribute to this effort. It's something that's remained very near and dear to my heart because as far as I understand there is still no device available on the market for this specific use and route of administration, so it remains an unmet need.
  
  
• How do you keep the patient at the heart of everything you do?
  I am enthusiastic about projects that address unmet needs. To give an example, I worked on a project that addresses an unmet need in treating hearing loss. The program involves a drug delivery system that can treat hearing loss as early as six months of age, which is remarkable. The client submitted a BLA and went through a pre-IND trial, which is currently in progress. This is currently in a clinical trial and they hope to receive FDA approval in the next three years. If approved, this drug delivery system will be a game-changer for people with all forms of hearing loss, not just those with adult-onset or sudden hearing loss. It can treat infants born with hearing loss. Many of us know someone who has experienced hearing loss, so it can be a personal issue as well. At Parexel, we hire people who love what they do, because it shows how much they love who they do it for.

• What does the Parexel brand promise "We Care" mean to you?
  I remember when Parexel rolled out the new brand promise of "We Care" and thought what a daring move that was... to uphold that commitment as a company will not only invite scrutiny but will keep everyone honest. So, with the unexpected global challenges of the last few years, I've been both impressed and proud of how Parexel continues to keep the staff and our clients, and their patients at the heart of key decisions.

• What makes a great leader in your opinion and how do you implement these into your leadership?
  I personally do not differentiate between a good vs. great leader. In my opinion, you are either a leader or you are a supporter – of which we need both. Leaders are servants – they lead by example, not by direction, and put others' interests ahead of their own. They are the voice of those they serve and are pioneers in exploring areas that will offer greater prosperity for their constituents. They humbly embrace leadership as a coveted responsibility knowing at times that the journey may not be easy, but the outcome will be beneficial to all. Leaders are willing to fall on the proverbial sword for others and not themselves.
  
  
• Tell me something most people don’t know about you.
  Most people do not know that my career goal was to become a veterinarian and during my junior and senior years of undergraduate college, I was interviewed and wait-listed both times for the University of Pennsylvania’s Veterinary School in Philadelphia. After having spent several years working for a local veterinary practice, I realized that my interest was more research-driven and, hence my professional path led me to where I am now…supporting human patients. First I was in research and development, then I moved into quality for over-the-counter drugs and from there on I got bitten by the regulatory bug! I wanted to engage more with the FDA and enjoyed learning about their on-site inspections. While I currently focus on human health, I still have a passion for animal health and behavior and often field informal questions from family and friends…especially when it comes to training German Shepherds.

• What is your untrainable superpower?
  This is a fun question! I can only answer this question based on feedback from others which over the course of my life, I’ve been told that I am very intuitive. It can be both a blessing and a curse but has definitely helped me dodge a few awkward situations.
  
  
• What do you enjoy when you’re not at work?
  When not at work, I enjoy spending time with my husband, two teenage children, and my very large German Shepherd. I especially love to get away to Cape May, New Jersey, and to our cabin in northern Pennsylvania. I also practice yoga, write poetry, landscape/home decor, cook, read, dance, go antiquing, enjoy motorcycle rides on our Harley Davidson, and spend time at the nostalgia superstock raceways where we showcase our two vintage cars.