Director / Senior Director of Regulatory Affairs

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.

If you’re driven by purpose, energized by complexity, and want to apply AI, biology, or both to redefine the future of drug development, come build Pathos with us.

About the role Pathos is seeking a Head of Regulatory Affairs to lead the regulatory function across the organization. This individual will own regulatory strategy and execution across our oncology pipeline and serve as the primary sponsor representative to the FDA.

This is a strategic and hands-on role. In a small and growing biotech, you will define regulatory strategy while directly leading core IND lifecycle activities, regulatory submissions, and agency interactions.

Key Responsibilities FDA & Agency Leadership

• Serve as the primary sponsor representative and day-to-day FDA contact

• Manage regulatory correspondence and information requests

• Lead preparation and authorship of FDA meeting packages (e.g., pre-IND, Type B/C, EOP meetings)

• Represent Pathos in health authority interactions IND Lifecycle Ownership

• Own ongoing maintenance of active INDs across their full lifecycle

• Prepare and submit IND amendments and annual reports

• Lead cross-functional authorship of DSURs (in collaboration with Safety, Biostatistics, and Data Management)

• Oversee and author Investigator’s Brochure (IB) updates Regulatory Submissions & Operations

• Oversee eCTD publishing (directly or via management of an external publishing vendor)

• Ensure submission quality, completeness, and timeliness

• Maintain regulatory submission timelines and infrastructure Compliance & Transparency

• Manage ClinicalTrials.gov listings and reporting

• Ensure regulatory compliance and inspection readiness

Strategic Leadership

• Develop regulatory strategies aligned with clinical development goals
• Advise leadership on regulatory risks and pathway considerations
• Support planning for future NDA/BLA strategy as programs advance

Qualifications

Required

• 12+ years of regulatory affairs experience in biotech or pharmaceutical development

• Deep experience in oncology drug development

• Direct IND lifecycle management experience

• Demonstrated experience serving as sponsor representative to FDA

• Hands-on experience authoring: •

• DSURs

• IND amendments and annual reports

• Investigator’s Brochure updates

• FDA meeting packages

• Experience overseeing eCTD submissions

• Familiarity with ClinicalTrials.gov reporting requirements

• Excellent written and verbal communication skills Preferred

• Experience in a small or growing biotech environment

• Experience with precision medicine or biomarker-driven programs

• 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.