Associate General Counsel – Regulatory and Technology

About the role

This role is one of the most direct applications of legal expertise to the treatment of cancer. You will be the primary legal advisor to the engineering, product, and clinical and operations teams building four of the company’s core platforms: the Oncology Foundation Model, AI Platform Foundry, Scout (asset identification), and Sprint (clinical trial execution).

Key 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. For instance, Finance will own tax compliance, but you’ll be owning the privacy program
• Uplevel and own the company’s compliance program
• Maintain organized digital spreadsheets of everything
• Learn and use AI to force multiply yourself across legal workstreams

Regulatory Counseling

• Advises on FDA regulatory strategy and classification for all components of the AI platform, including implications for development, commercialization, and IND/NDA/BLA submissions (FDA submissions will be owned by Regulatory Affairs)
• Advises 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

Product and Technology Counseling

• Informs and reviews tech product specs, system architectures, and data flow designs for regulatory risk before build and deployment
• Develops 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
• Advises on data governance, data integrity, chain-of-custody, and 21 CFR Part 11 requirements for clinical data across company systems and third-party infrastructure
• Structures HIPAA and applicable data privacy frameworks; develops and maintains internal regulatory policies and compliance frameworks for AI tool development and deployment
• Tracks and assesses evolving AI regulation (EU AI Act, FDA AI governance frameworks, state laws) for applicability to company activities

Who you are

• 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
• While this role requires no scientific background, you'll work alongside world class researchers and technologists in a state of the art facility, and will need to be able to match the pace of the rest of the team
• Track record of building regulatory strategy from first principles and owning a regulatory and technical narrative with pharma partners, investors, and regulators
• You notice when something is out of place and fix it - without being asked or waiting to see if someone else notices and does it first
• Thrives in ambiguity. You're comfortable working without a playbook, you figure it out, get it done, and write the process down so it's faster next time.
• Familiarity with clinical data standards, real-world evidence, biomarker qualification, or adaptive trial design.