RNA-therapeutic company entering clinical development

(Staff Scientist) I joined as the first member of the biomarker team as the company transitioned into clinical development. I worked across teams to build the scientific foundation for the biomarker strategy by reviewing FDA documentation and communications from previous submissions, developing relationships with KOLs and CROs, and learning the needs of the medical providers and patients in the rare disease community. This led to new collaborations and successful procurement of very rare human samples.

I led biomarker assay development, including designing an assay for a target with no existing detection method. I presented high-level plans to senior leadership and coordinated weekly with cross-functional teams including Regulatory Affairs, Clinical Development, and Clinical Operations to work through plans and help direct their work. As the team grew, I onboarded new hires with one-on-ones focused on the science and the reasoning behind our strategy.