Director / Senior Director of Regulatory Affairs

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

This role is unique because it involves building AI-powered regulatory workflows from the ground up. 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

• Author and submit IND amendments
• Prepare annual reports
• Lead DSUR development in collaboration with safety, biostatistics, and data management
• Maintain IB currency across all active studies
• Oversee ClinicalTrials.gov listings
• Ensure all regulatory commitments and timelines are tracked and met

Submission Operations

• Oversee eCTD publishing and submission infrastructure
• Manage external publishing vendors where needed
• Set quality standards for all regulatory submissions leaving Pathos
• Build and maintain SOPs, controlled document systems, and records management infrastructure

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

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

Qualifications

• 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

Location

This is a hybrid role, requiring up to 3 days per week onsite, in our NYC Headquarters.

Pay Range

220,000 - 300,000 USD per year (New York Office)