Drug development shouldn’t be guesswork, not when patients are waiting. Pathos is building a next-generation biotech with AI at the core. Not as a feature, but as the operating system for how medicines get developed. Backed by NEA.
About the role
You will own the IND lifecycle across our oncology pipeline. That means authoring DSURs, preparing IB updates and IND amendments, building FDA meeting packages, managing ClinicalTrials.gov listings, and overseeing eCTD publishing. You will be the person FDA knows and the person accountable for every submission that leaves Pathos.
What they're looking for
- 10 or more years of regulatory affairs experience in biotech or pharmaceutical development, with deep oncology experience
- Direct IND lifecycle management experience: you have owned INDs from filing through amendment cycles, authored DSURs, prepared IB updates, and built FDA meeting packages as the primary author
- Proven FDA sponsor representative experience: you have managed the agency relationship directly across multiple programs, not as a supporting contributor but as the accountable lead
- Experience as a first or early regulatory hire at a small or growth-stage biotech where you built processes and infrastructure without a large team behind you
- Comfort working alongside software and ML engineers to build and iterate on systems: you do not need to be an engineer, but you need to be genuinely curious about how these tools work and excited to direct them
- A belief that AI-assisted regulatory workflows represent the future of how this function operates, and a willingness to operate that way now rather than eventually
More about this role
You will own the IND lifecycle across our oncology pipeline. That means authoring DSURs, preparing IB updates and IND amendments, building FDA meeting packages, managing ClinicalTrials.gov listings, and overseeing eCTD publishing. You will be the person FDA knows and the person accountable for every submission that leaves Pathos.
What makes this role different is how the work gets done. Pathos is building AI-powered regulatory workflows from the ground up, and you will be at the center of that build. You will direct AI agents to handle the execution layer of regulatory tasks, apply your expert judgment to review and finalize outputs, and work with our engineering teams to make those systems more capable over time. The goal is not to remove the regulatory expert from the process. It is to make that expert exponentially more productive.
IND Lifecycle Management
Own the full IND lifecycle for Pathos's oncology pipeline. Author and submit IND amendments, prepare annual reports, lead DSUR development in collaboration with safety, biostatistics, and data management, and maintain IB currency across all active studies. Oversee ClinicalTrials.gov listings and ensure all regulatory...
Browse similar: Startup jobs