PATHOS

• Advise on all things regulatory. Drug development, privacy, corporate compliance, AI guidelines, etc. • Own all things regulatory + compliance that don’t already have a home outside Legal. • Maintain organized digital spreadsheets of everything • Advise on FDA regulatory strategy and classification for all components of the AI platform, including implications for development, commercialization, and IND/NDA/BLA submissions. • Advise on protocol development, site monitoring, data integrity, biomarker qualification, companion diagnostic considerations, the use of real-world data, etc. • Monitor and interpret evolving FDA guidance on AI/ML in drug development and translate into actionable guidance for internal teams • Support direct engagement with the FDA and other agencies on novel questions when warranted, including in global clinical programs • Review external content such as conference publications for regulatory issues • Inform and review tech product specs, system architectures, and data flow designs for regulatory risk before build and deployment • Develop working knowledge of the company’s technical stack — cloud infrastructure, data pipelines, storage systems, and model architecture — sufficient to accurately represent those systems to regulators, partners, and investors • Advise on data governance, data integrity, chain-of-custody, and 21 CFR Part 11 requirements for clinical data across company systems and third-party infrastructure • Track and assess evolving AI regulation (EU AI Act, FDA AI governance frameworks, state laws) for applicability to company activities