Director, Senior Legal Counsel, R&D Legal

About the role

The Director, Senior Legal Counsel, R&D Legal provides strategic legal support for Research and Development activities across the Americas, covering Research and Early Development, Clinical Operations and Development Units, to advance the organization's innovative pipeline. The role must be based in Cambridge, MA or East Hanover, NJ.

Key responsibilities

• Provide legal counsel on FDA regulatory requirements, development strategies, human subject protection, GxP compliance, research governance, data use and sharing, AI-enabled research and other R&D legal and regulatory issues.
• Support integration of acquired assets and programs, including regulatory and R&D legal guidance on development programs, regulatory obligations, quality systems and operational transitions.
• Help identify and assess emerging legal, regulatory, technology and geopolitical developments affecting global R&D.
• Support legal strategies and risk mitigation for cross-border data exchange, technology transfers, collaborations and research in strategically significant jurisdictions.
• Provide legal support for clinical development and study operations, including research privacy, informed consent, site selection, patient recruitment, IRB approvals, decentralized trials, study fees and data integrity.
• Support U.S. Biomedical Research and partner with Security & Legal, R&D, quality and regulatory on the legal implications of AI, helping its responsible adoption and the transformation of legal services.
• Review Novartis policies, governance frameworks, operating procedures and training materials for compliance and risk management.

Required profile

• J.D. or equivalent law degree and admission to practice in at least one U.S. jurisdiction.
• 8+ years of post-bar legal experience in life sciences (preferably biotechnology or pharmaceutical) or a top-tier law firm advising pharmaceutical clients.
• Significant knowledge of FDA law and regulation, including drug R&D, regulatory strategy, clinical development, approval pathways, GxP compliance, inspection readiness and enforcement.
• Experience supporting development, clinical operations, quality or related R&D organizations in a pharmaceutical or biotechnology setting.
• Ability to work in global, cross-functional, cross-border teams and to learn new subject matter quickly.

Required skills

• Strong strategic and analytical skills and sound judgment on complex, ambiguous issues.
• Ability to turn complex legal concepts into practical business advice.
• Interest in emerging technologies, AI and evolving regulatory frameworks.

What we offer

• Expected salary of $194,600 to $361,400 per year, with a performance-based cash incentive and possible annual equity awards.
• Health, life and disability benefits, 401(k) with company contribution and match, and a time-off package including vacation, personal days and holidays.