I help our clients navigate the regulatory complexities. And I do it
Meet Steve: A Day in the Life of a VP Technical at Parexel
"I always think of the VP Tech’s as ambassadors for Parexel, since we’re front and center when it comes to helping our clients navigate the regulatory complexities of the development program and interacting with Health Authorities as the product moves from first-in-human trials toward licensure and post-marketing."
Embark on the remarkable career journey of our VP Technical, Steve, who began his professional path at the FDA, regulating cardiovascular cell and gene therapy trials. Transitioning to Parexel, he now plays a crucial role in steering our clients through the intricate regulatory landscapes essential for advancing medical innovations from initial trials to market success. As a key ambassador for Parexel, Steve merges deep regulatory insights with strategic business solutions, enhancing our client engagements and driving forward the development of safe and effective products.
Discover how a VP Technical's day unfolds with a blend of client interactions, strategic meetings, and thought leadership, all aimed at shaping the future of healthcare through tailored regulatory strategies.
Could you tell us a little about your career to date?
I was recruited by CBER/FDA to be a Medical Officer in the cell and gene therapy office (called OCTGT at the time, now called OTP) from the National Heart, Lung, and Blood Institute (NHLBI) in the National Institutes of Health (NIH), where I had been doing research in the Laboratory of Molecular Cardiology as part of the NIH Clinical Associate program. At that time, FDA was looking for someone to oversee the cardiovascular cell and gene therapy INDs, and I ended up covering over 90% of those files during my 11-year tenure at FDA, first as a Primary Clinical Reviewer, then later as Team Lead, and finally as Acting Branch Chief. Although the main requirement for a Medical Officer is an M.D. degree, I feel that getting a solid background in Molecular Biology really set me up for a rewarding career in regulating cell and gene therapies at FDA.
What do the responsibilities of VP Technical look like?
Our overall function is to either work directly with our clients on Regulatory issues, or together with Parexel’s other business units, such as the clinical trial operations team, to come up with integrated solutions for various issues that arise during development. I always think of the VP Tech’s as ambassadors for Parexel, since we’re front and center when it comes to helping our clients navigate the regulatory complexities of the development program and interacting with Health Authorities as the product moves from first-in-human trials toward licensure and post-marketing.
How would you describe the daily routine of a VP Technical?
We have internal meetings a few days a week to go over things such as key learnings that can enrich our daily work, updates on our progress in new business activities, and new initiatives for our business unit from Management; however, the bulk of each day is split between billable activities (e.g., working on either authoring or reviewing client Briefing Documents for HA meetings, serving on client Advisor Boards, answering Regulatory questions from clients) and non-billable work (e.g., working on development of training courses and what we call Thought Leadership activities that include authoring blogs/articles and presenting at conferences).
What are important considerations for the VP Technical role?
At the heart of what we do for clients is coming up with tailored solutions that can expedite the rational development of safe and effective products, so that’s always something to keep in mind when working on any project. I’ve always found that being able to triage different projects to address urgent needs of clients can help foster a fulfilling, ongoing partnership between Parexel and its clients, since availability and dependability are important attributes that clients are looking for in consultants.
How does your team work with clients?
Most of the Cell & Gene Therapy (CGT) clients that I work with are small-to-medium sized biotech companies. Having a clinical focus, I interact the most with our clients’ Clinical and Regulatory staff. Parexel’s Regulatory Strategy VP Tech’s view ourselves as collaborators with our clients. For a nascent field like CGT, nobody has all the answers yet, so we use our experience from working within Health Authorities, as well lessons learned from our clients’ interactions with HAs, so that we can provide generalized information on trends in HA regulatory perspectives to be able to engage in substantive discourse with our clients. A main focus is helping clients avoid potential pitfalls during development
Parexel is commonly recognized in the industry as 'Parexel University'. What opportunities has Parexel provided to you during your career?
One of the reasons why I came to Parexel is for the rich learning environment that comes from formal training programs to keep us up to date on developments in our fields of interest, as well as from the daily learning that you get from interacting with esteemed colleagues in Regulatory and other business units who bring a wealth of diverse expertise. Our CGT Center of Excellence prides itself on being able to offer clients an integrated, multi-disciplinary service offering, since we’ve found that the most successful CGT programs solve issues in a way that incorporates numerous perspectives.
What would you say are a VP Technical’s ‘must-have’ skills?
Some of the most important skills are critical thinking and ability to adapt prior learnings from similar regulatory situations to help clients come up with individualized solutions for their unique issues. At Parexel, VP Tech’s are key drivers of new business, so having a comfort level in what one of my mentors used to call “the soft side” of consulting, such as good communication skills, is extremely important – for example, being able to effectively convey your enthusiasm for a project by thinking through issues for which you weren’t explicitly asked by the client, really speaks to the work ethic and sense of initiative that Parexel fosters for all of its consultants, which doesn’t go unnoticed by clients.
What do you enjoy outside of work?
Being based in Arizona, I really like being able to take in the beautiful outdoors. I love playing and watching sports of all kinds, but I particularly enjoy golf. I’m also a movie buff. But above all, I enjoy spending quality time with my family, which I’m afforded by the work-life balance that Parexel encourages.
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