Jonathan Douek - Episode 12 - Regulatory Voices

<p>In this next episode of <a rel="noopener noreferrer nofollow" href="https://www.linkedin.com/company/regulatory-voices/" target="_blank"><b>Regulatory Voices</b></a>, I sit down with <a rel="noopener noreferrer nofollow" href="https://www.linkedin.com/in/jonathan-douek-pharmd-ms-86567129/" target="_blank"><b>Jonathan Douek, PharmD, MS</b></a>, Senior Director and Global Head of Regulatory Affairs at <a rel="noopener noreferrer nofollow" href="https://www.linkedin.com/company/oncolytics-biotech-inc./" target="_blank"><b>Oncolytics Biotech Inc.</b></a><br /><br />Jonathan’s career has taken him from an FDA externship and early regulatory roles at Amgen, through a rapid progression at Dynavax, to leading global regulatory strategy within a clinical-stage oncology biotech.<br /><br />This was a really honest conversation about building a regulatory career without a perfect roadmap, growing into leadership before you necessarily feel finished, and the realities of oncology combination development.<br /><br />In this episode, we discuss:<br /><br />How Jonathan created his own route into Regulatory Affairs after fellowship rejections, and the role mentorship and relationship-building played throughout his career.<br /><br />What large pharma gave him early on, what changed when he moved into a smaller company, and how he adapted when he unexpectedly found himself operating as an interim regulatory leader.<br /><br />Why experience matters more than titles, and why he is deliberately focused on building the right foundations rather than rushing towards the next position.<br /><br />Contribution of components in modern oncology development, why it becomes especially challenging in rare disease settings, and why smaller companies need to consider it much earlier than the registrational stage.<br /><br />We also discuss FDA interactions, regulatory strategy as a constantly evolving process, and why failures, delays and setbacks are often where some of the most important career lessons are learned.<br /><br />Thank you again Jonathan, it was a pleasure to record this episode.<br /><br />Regulatory Voices is powered by <a rel="noopener noreferrer nofollow" href="https://www.linkedin.com/company/codon-partners/" target="_blank"><b>Codon Partners</b></a>, a US focused Life Science Staffing company.</p>