I navigate the complex landscapes of clinical trials by putting patients first. And I do it
Meet Sinan, Senior Vice President, Head of Oncology Europe, Regulatory Consulting
Meet Sinan, whose career journey is a testament to the growth and opportunities at Parexel. Sinan enjoys and appreciates the direct influence his work has on ensuring patient safety and product efficacy. This ongoing sense of motivation and pride continues to inspire him in his professional endeavors.
Let Sinan's story inspire you to explore how far your expertise and enthusiasm can take you at Parexel.
What brought you to Parexel's Regulatory team?
I joined Parexel's Regulatory group in 2022 as Vice President (VP Technical), bringing with me over a decade of invaluable experience from the Danish Medicines Agency. I joined the Regulatory team at Parexel because I saw it as the perfect opportunity to utilize my knowledge and further enhance my experience in the field of regulatory consulting. I strongly believe that this role allows me to apply my expertise and contribute effectively to the team.
Could you tell us a little about your career to date?
I began my regulatory career as a Senior Medical Officer at the Pharmacoviligance and Medical Devices department at the Danish Medicines Agency, but moved quickly to the Licensing Division, where I joined the Cancer Team. I was the lead clinical assessor on countless oncology products, where several are standard of care now. Shortly after joining the Cancer Team, I was nominated as a Member of the Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMA) and also CHMP’s Oncology Working Party (ONCWP). I became the Chair of ONCWP later, where I was responsible for driving the EMA’s guidelines and policies in oncology. As a member of ONCWP and later a member of CHMP, I had monthly meetings with the FDA’s Oncology Center of Excellence (OCE) to discuss ongoing procedures, guidelines, designations, scientific advice, etc. This gave me an in-depth understanding of the guidelines, policies, and decisions at the OCE. I was nominated as a Member of CHMP in 2015, and shortly thereafter I was appointed chief medical officer at the Danish Medicines Agency. Based on my experience, I can provide a solid understanding of the regulatory landscape, the regulatory requirements, but also the clinical requirements.
What does your role as VP Technical look like?
I provide strategic, regulatory, and clinical advice about the development of products, pre-IND, IND, NDA, BLA, MAA, ODD, PRIME, Fast track, Breakthrough designation, high-stake meetings, etc. Reviewing and providing gap analysis on important documents before submission to the FDA and EMA and preparing due diligence assessment reports for different clients. I interact a lot with new and existing clients.
What does a typical day of a VP Technical consists of?
No two days are ever the same, which is what makes this role so exciting! At Parexel, the nature of our work in the Regulatory team is highly diverse and tailored to the specific needs of our clients. The range of projects and development programs we handle varies based on the client and the type of products involved. For instance, we might assist a prominent pharmaceutical company in exploring potential expanded uses for their existing products. On the other hand, we may provide comprehensive guidance and support for a startup biotech company in their new Investigational New Drug (IND) submission, as they may lack in-house regulatory expertise. The dynamic nature of these assignments is what makes our work at Parexel incredibly interesting and engaging.
What factors are crucial to consider for the VP Technical role?
Working as a VP Technical is like being in an emergency room—intellectually stimulating, fast-paced, and requiring quick adaptation as we pivot between diverse projects and clients with unique needs. It is crucial to have the ability to adapt quickly and embrace new ideas that may challenge our existing beliefs.
What aspect of your job do you feel most passionate about?
I'm truly passionate about championing clients with groundbreaking innovations and novel trial designs - it's where science meets creativity, and where we can make the most meaningful difference in advancing healthcare. This allows me to expand my technical knowledge and forces me to deeply contemplate how we can effectively present and justify these innovations to regulatory authorities.
What are ‘must-have’ skills needed for the VP Technical’s role?
VP Tech's are expected to have the highest technical skills, but this alone doesn’t make one a great VP Tech. More importantly, you need to have that “helicopter view” that allows you to have a vision for a given product, and how to get it to the market in a timely manner, for the benefit of patients and society in general.
How do you work With Heart™ and what does it mean to you?
Working With Heart™ means balancing scientific rigor with unwavering commitment to patients - they're not just data points but the very reason behind everything we do at Parexel. At the end of the day, it is the patient that matters.
What's the one insight about working at Parexel you'd share with someone considering joining our team?
If you are looking to shape the future of drug development, consider joining my team. My experience at the EMA showed me that by the time a product reached our desks, its path was largely set in stone, with a completed pivotal study leaving us with a binary choice: approve or deny. Here, we encounter our clients at a much earlier stage, allowing us to actively influence and guide their direction, offering a unique chance to truly impact the trajectory of a drug's journey
What do you enjoy outside of work?
I love to read, and it has been a passion since childhood. I particularly enjoy the classics. More importantly, I enjoy the long “walks-and-talks” with my dear wife in the surrounding parks and sea promenade. Finally, I enjoy watching my favorite football club and try to see some of their matches when time allows.
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