R&D Legal Director — FDA Strategy & AI Compliance

BioNJ Inc.; East Hanover (NJ); On-site; USD 195,000 - 361,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Paid time off

Job summary

Novartis seeks a Director, Senior Legal Counsel, R&D Legal to provide strategic legal support for Americas R&D activities, including early development and Clinical Operations, to advance the company’s pipeline.

Based in Cambridge, MA or East Hanover, NJ, this role collaborates with cross-functional teams to address FDA regulatory requirements, data use, governance, and AI-enabled research, delivering practical, risk-based legal advice for development programs.

Qualifications

• J.D. or equivalent law degree and bar admission in at least one US jurisdiction.
• 8+ years of post-bar legal experience in life sciences or top-tier law firm advising on complex risks.
• Strong knowledge of FDA law, regulatory strategy and GxP compliance.
• Experience supporting R&D, clinical ops, quality, or related functions in pharma/biotech.
• Ability to translate complex legal concepts into practical business advice.
• Interest in AI, regulatory frameworks, and global/ geopolitical factors.

Responsibilities

• Provide sophisticated legal counsel on R&D activities in the Americas with emphasis on the U.S.
• Advise on FDA regulatory requirements, development strategies, and data use/sharing.
• Support integration of acquired assets with regulatory and quality considerations.
• Identify emerging legal/regulatory developments affecting global R&D.
• Advise on cross-border data exchange, technology transfers, and collaborations.
• Support clinical development and study operations with privacy and consent considerations.
• Collaborate with Security, R&D, quality and regulatory teams on AI use in research.
• Review Novartis policies and governance to ensure compliance and risk management.

Skills

Regulatory strategy

FDA knowledge

Cross-functional leadership

Risk assessment

Strategic thinking

Analytical thinking

Education

Juris Doctor (J.D.)

Bar admission in US

Job description

Novartis seeks a Director, Senior Legal Counsel, R&D Legal to provide strategic legal support for Americas R&D activities, including early development and Clinical Operations, to advance the company’s pipeline.

Based in Cambridge, MA or East Hanover, NJ, this role collaborates with cross-functional teams to address FDA regulatory requirements, data use, governance, and AI-enabled research, delivering practical, risk-based legal advice for development programs.