Associate General Counsel – Regulatory and Technology
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Job Description
Legal advisor guiding regulatory compliance and FDA strategy for AI-driven cancer treatment platforms. Collaborating with engineering, product, and clinical teams to ensure legal alignment.
Responsibilities:
- 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
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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