Jonathan Douek - Episode 12 - Regulatory Voices

In this next episode of Regulatory Voices, I sit down with Jonathan Douek, PharmD, MS, Senior Director and Global Head of Regulatory Affairs at Oncolytics Biotech Inc.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.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.In this episode, we discuss:How Jonathan created his own route into Regulatory Affairs after fellowship rejections, and the role mentorship and relationship-building played throughout his career.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.Why experience matters more than titles, and why he is deliberately focused on building the right foundations rather than rushing towards the next position.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.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.Thank you again Jonathan, it was a pleasure to record this episode.Regulatory Voices is powered by Codon Partners, a US focused Life Science Staffing company.