R&D Legal Strategy Director — FDA & AI Leadership

Novartis AG; Cambridge (MA); On-site; USD 195,000 - 361,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Equity awards eligibility

Job summary

Novartis AG in Cambridge, MA (or East Hanover, NJ) seeks a Director, Senior Legal Counsel, R&D Legal to provide strategic US/Americas legal support for R&D activities, including FDA regulatory compliance, data use, and governance across development programs.

The role requires a JD, US bar admission, and 8+ years in life sciences/pharma, with strong strategic, analytical capabilities and AI-related governance interest. Based in Cambridge or East Hanover with cross-border responsibilities.

Qualifications

• J.D. and US bar admission required.
• 8+ years post-bar legal experience in life sciences or pharma.
• Significant knowledge of FDA law and regulation.
• Experience supporting development, clinical operations, quality, or R&D in pharma/biotech.
• Strong strategic and analytical skills; ability to translate legal concepts.

Responsibilities

• Provide sophisticated legal counsel on R&D activities in the Americas, including FDA/regulatory matters.
• Support integration of acquired assets with regulatory and R&D guidance.
• Identify emerging legal, regulatory, technology, and geopolitical developments affecting global R&D.
• Advise on legal implications of evolving business models and cross-border data exchanges.
• Support clinical development and study operations in the Americas as needed.
• Collaborate with Security & Legal, R&D, quality and regulatory teams on AI use in R&D.

Skills

FDA regulatory

Regulatory strategy

Legal risk management

Cross-functional leadership

Data privacy

Education

J.D. or equivalent

US bar admission

Job description

Novartis AG in Cambridge, MA (or East Hanover, NJ) seeks a Director, Senior Legal Counsel, R&D Legal to provide strategic US/Americas legal support for R&D activities, including FDA regulatory compliance, data use, and governance across development programs.

The role requires a JD, US bar admission, and 8+ years in life sciences/pharma, with strong strategic, analytical capabilities and AI-related governance interest. Based in Cambridge or East Hanover with cross-border responsibilities.