Regulatory & Technology Counsel for AI-Driven Biotech

Pathos; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Pathos is seeking a primary legal advisor to support the engineering, product, and clinical teams in the development of AI platforms for cancer treatment. This role requires FDA drug development law expertise and the ability to understand complex data systems.

The successful candidate will thrive in ambiguity, possess a J.D. from a top law school, and have at least 7 years of experience in relevant legal environments. This position offers the opportunity to create a regulatory infrastructure from scratch and engage with innovators in the biotech field.

Qualifications

• 7+ years of legal experience, preferably with in-house experience in tech/biotech.
• Experience with IND/NDA/BLA lifecycle, GCP, and AI/ML regulatory frameworks.
• Familiarity with clinical data standards and real-world evidence.

Responsibilities

• Advise on FDA regulatory strategies related to AI platforms.
• Develop and maintain compliance programs for privacy and data governance.
• Engage with internal teams on technical specifications and data flow designs.

Skills

FDA drug development law

Regulatory compliance

Data governance

Technical aptitude

Cloud infrastructure understanding

Education

J.D. from a top law school

Job description

Pathos is seeking a primary legal advisor to support the engineering, product, and clinical teams in the development of AI platforms for cancer treatment. This role requires FDA drug development law expertise and the ability to understand complex data systems.

The successful candidate will thrive in ambiguity, possess a J.D. from a top law school, and have at least 7 years of experience in relevant legal environments. This position offers the opportunity to create a regulatory infrastructure from scratch and engage with innovators in the biotech field.