PATHOS logo
PATHOS

Connect Minds. Build Brands.

Associate General Counsel – Regulatory and Technology

Location

United States

Posted

3 days ago

Salary

0

Seniority

Mid Level

Postgraduate Degree7 yrs expEnglishCloudGoogle Cloud Platform

Job Description

Associate General Counsel – Regulatory and Technology

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

Job Requirements

  • J.D. from a top law school and active bar admission
  • 7+ years of legal experience with substantial in-house time, preferably at a high-growth technology / biotech company
  • Existing expertise in drug development law: IND/NDA/BLA lifecycle, GCP, 21 CFR Part 11, and regulatory frameworks governing AI/ML tools and software in drug development
  • Demonstrated experience advising engineering or product teams, with the ability to understand and accurately articulate complex technical systems — cloud infrastructure, data pipelines, ML model architecture — without being a practitioner
  • Track record of building regulatory strategy from first principles and owning a regulatory and technical narrative with pharma partners, investors, and regulators
  • Familiarity with clinical data standards, real-world evidence, biomarker qualification, or adaptive trial design.

Benefits

  • Health insurance
  • Paid time off
  • Flexible work arrangements
  • Professional development opportunities

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