Director, Senior Legal Counsel, R&D Legal

The Director, Senior Legal Counsel, R&D Legal will be responsible for providing strategic legal support for Research & Development activities across the Americas, including Research and Early Development, Clinical Operations, and Development Units to advance the organization’s innovative pipeline.

This person must be based in Cambridge, MA or East Hanover, NJ.

• Provide sophisticated legal counsel on a broad range of issues arising from R&D activities in the Americas and primarily in the U.S., including FDA regulatory requirements and development strategies, human subject protection, GxP compliance, research governance, data use and sharing, AI-enabled research, and other legal and regulatory issues impacting research and development of innovative medicines.
• Support integration of acquired assets and programs by providing strategic regulatory and R&D legal guidance on development programs, regulatory obligations, quality systems, and operational transition matters.
• Support the Head of R&D Legal, Americas in identifying and assessing emerging legal, regulatory, technology, and geopolitical developments impacting global R&D activities and strategic business objectives.
• Support legal strategies and risk mitigation measures related to evolving business models, including cross-border data exchange, technology transfers, integration of acquired assets and capabilities, collaborations, and research activities involving strategically significant jurisdictions.
• Provide legal support for clinical development and study operation activities in the Americas as needed for key initiatives, priority matters and business continuity coverage. Areas of legal support include research privacy and informed consent, site selection, patient recruitment and retention, institutional review board negotiations and approval, decentralized trials, study fees and fair market value, data use and sharing, and scientific and data integrity.
• Provide legal support for U.S. Biomedical Research (BR) as needed for key initiatives, priority matters and business continuity coverage.
• Partner with key stakeholders across Security & Legal, R&D, quality and regulatory to advise on the legal implications of the use of AI. Support the responsible and ethical adoption of AI within R&D activities and help advance the transformation of legal service delivery through AI-enabled solutions, processes, and ways of working.
• Legal review and advice on Novartis policies, governance frameworks, operating procedures, and training materials to ensure compliance with legal and regulatory requirements and promote effective risk management.

• Juris Doctor (J.D.) or equivalent law degree and admission to practice law in at least one U.S. jurisdiction.
• 8+ years’ post bar admission legal experience in life sciences industry (preferably biotechnology or pharmaceutical) or a top-tier law firm representing pharmaceutical clients and advising senior leaders on complex legal, regulatory, and business risks.
• Significant knowledge of FDA law and regulation, including drug research and development, regulatory strategy, clinical development, approval pathways, GxP compliance, inspection readiness and enforcement matters.
• Significant experience supporting development, clinical operations, quality, or related R&D organizations within a pharmaceutical or biotechnology environment.
• Strong strategic and analytical skills, with the ability to assess novel legal, regulatory, and business issues in rapidly evolving environments.
• Demonstrated sound judgment and ability to provide practical, risk-based legal advice on complex and ambiguous issues.
• Demonstrated ability to learn new subject matter quickly and translate…