Director, R&D Legal, Americas

Novartis - Cambridge, MA

Hiring: Director, R&D Legal, Americas Company: Novartis Location: Cambridge, MA Job Posted Time: 2026-09-10 10:21:07 Target Skills & Keywords : R About the job Experience: •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. Required Skills: •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. •Actively facilitate and support 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 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. Qualifications: •Juris Doctor (J.D.) or equivalent law degree and admission to practice law in at least one U.S. jurisdiction. •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 complex legal concepts into practical business advice. •Intellectual curiosity and interest in emerging technologies, AI, evolving regulatory frameworks, geopolitical and external factors shaping the future of pharmaceutical research and development. •Demonstrated capacity to operate effectively in an increasingly global and interconnected environment involving cross-functional, cross-border, and multidisciplinary teams. Compensation: •$361,400 per year •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!