What are the responsibilities and job description for the Director / Senior Director of Regulatory Affairs position at Pathos?
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. We believe most drugs don’t fail because the science was wrong. They fail because they were tested in the wrong patients, with the wrong assumptions, in trials that couldn’t answer the real question: who benefits, and why?
Pathos exists to change that. We’re building the largest foundation model in oncology and pairing it with proprietary AI systems, deep oncology expertise, and 200 petabytes of multimodal data linked to patient outcomes, so we can make development decisions with more precision, much earlier.
This is not theoretical. We’re well-capitalized and have the leadership to build a generational company. We invest in and advance our own clinical-stage programs, using our AI platform to sharpen trial design, patient selection and biomarker strategy. So therapies reach the patients most likely to benefit, sooner.
How We Build
Pathos does not operate like a traditional biotech. There is no middle management. There are no layers of approval. The company is designed, from the ground up, around small teams of 2–4 subject-matter experts who each command hundreds of AI agents to do the work that used to require dozens of people.
Everyone builds. Everyone ships. Every function at Pathos — from clinical execution to asset selection to the foundation model itself — runs on this model. Our product velocity delivers meaningful outcomes in hours instead of weeks. This is not a future aspiration. It is how we operate today.
The people who thrive here are operators: deep experts who can specify what needs to happen, orchestrate AI agents to execute at scale, and make high-judgment calls that compound over time. If you have spent your career building and shipping AI systems at scale, this is the environment where that experience becomes a superpower.
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 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.
Key Responsibilities
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 commitments and timelines are tracked and met.
Submission Operations
Oversee eCTD publishing and submission infrastructure, managing external publishing vendors where needed. Set quality standards for all regulatory submissions leaving Pathos and ensure every package is accurate, complete, and inspection ready. Build and maintain the SOPs, controlled document systems, and records management infrastructure that support a growing pipeline.
Agentic Regulatory Workflows
Work with Pathos's software and machine learning engineering teams to build AI-powered systems that accelerate regulatory execution. Direct AI agents to generate first drafts of regulatory documents, flag inconsistencies, and surface relevant precedent. Apply your regulatory judgment as the expert reviewer who shapes, finalizes, and takes accountability for every output. As the function scales, your ability to orchestrate these systems will determine how many programs you can support simultaneously.
FDA Relationship
Serve as Pathos's primary sponsor representative with FDA across all active programs. Lead preparation of pre-IND meeting requests, Type B and Type C meeting packages, and End of Phase meetings. Engage proactively and frequently with FDA, particularly around Pathos's AI-enabled development model and novel trial designs.
Who You Are
This is a hybrid role, requiring up to 3 days per week onsite, in our NYC Headquarters.
The Pay Range For This Role Is
220,000 - 300,000 USD per year(New York Office)
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. We believe most drugs don’t fail because the science was wrong. They fail because they were tested in the wrong patients, with the wrong assumptions, in trials that couldn’t answer the real question: who benefits, and why?
Pathos exists to change that. We’re building the largest foundation model in oncology and pairing it with proprietary AI systems, deep oncology expertise, and 200 petabytes of multimodal data linked to patient outcomes, so we can make development decisions with more precision, much earlier.
This is not theoretical. We’re well-capitalized and have the leadership to build a generational company. We invest in and advance our own clinical-stage programs, using our AI platform to sharpen trial design, patient selection and biomarker strategy. So therapies reach the patients most likely to benefit, sooner.
How We Build
Pathos does not operate like a traditional biotech. There is no middle management. There are no layers of approval. The company is designed, from the ground up, around small teams of 2–4 subject-matter experts who each command hundreds of AI agents to do the work that used to require dozens of people.
Everyone builds. Everyone ships. Every function at Pathos — from clinical execution to asset selection to the foundation model itself — runs on this model. Our product velocity delivers meaningful outcomes in hours instead of weeks. This is not a future aspiration. It is how we operate today.
The people who thrive here are operators: deep experts who can specify what needs to happen, orchestrate AI agents to execute at scale, and make high-judgment calls that compound over time. If you have spent your career building and shipping AI systems at scale, this is the environment where that experience becomes a superpower.
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 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.
Key Responsibilities
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 commitments and timelines are tracked and met.
Submission Operations
Oversee eCTD publishing and submission infrastructure, managing external publishing vendors where needed. Set quality standards for all regulatory submissions leaving Pathos and ensure every package is accurate, complete, and inspection ready. Build and maintain the SOPs, controlled document systems, and records management infrastructure that support a growing pipeline.
Agentic Regulatory Workflows
Work with Pathos's software and machine learning engineering teams to build AI-powered systems that accelerate regulatory execution. Direct AI agents to generate first drafts of regulatory documents, flag inconsistencies, and surface relevant precedent. Apply your regulatory judgment as the expert reviewer who shapes, finalizes, and takes accountability for every output. As the function scales, your ability to orchestrate these systems will determine how many programs you can support simultaneously.
FDA Relationship
Serve as Pathos's primary sponsor representative with FDA across all active programs. Lead preparation of pre-IND meeting requests, Type B and Type C meeting packages, and End of Phase meetings. Engage proactively and frequently with FDA, particularly around Pathos's AI-enabled development model and novel trial designs.
Who You Are
- 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
- Active engagement with the evolving regulatory landscape for AI-enabled drug development, including FDA guidance on AI in drug development and its implications for how Pathos operates
- Familiarity with precision medicine and biomarker-driven oncology programs is a strong plus
- Familiarity with innovative trial designs or AI-enabled development approaches
This is a hybrid role, requiring up to 3 days per week onsite, in our NYC Headquarters.
The Pay Range For This Role Is
220,000 - 300,000 USD per year(New York Office)