Director, R&D Legal, Americas

Novartis; East Hanover (NJ); On-site; USD 150,000 - 210,000; Full time

Job summary

Scorpion Therapeutics in Cambridge, MA or East Hanover, NJ seeks a Senior Legal Strategist to support R&D across the Americas, with emphasis on U.S. FDA regulatory compliance for innovative medicines.

You will provide counsel on GxP, clinical development, data sharing, AI-enabled research, and cross-border collaborations, partnering with security, regulatory, and other teams to shape compliant strategy.

Qualifications

• J.D. or equivalent and admission to at least one U.S. jurisdiction.
• 8+ years post-bar legal experience in life sciences, preferably biotech/pharma.
• Expertise in FDA law, clinical development, GxP, and regulatory strategy.

Responsibilities

• Provide legal counsel on FDA regulatory requirements and GxP.
• Support integration of acquired assets.
• Advise on cross-border data exchanges and new business models.
• Support clinical and biomedical research activities, including privacy and data use.
• Partner with security, regulatory, and other teams on AI ethics and legal frameworks.
• Review policies and training for compliance.

Skills

FDA/Regulatory law

GxP compliance

Clinical development knowledge

AI ethics awareness

Cross-functional collaboration

Analytical skills

Education

J.D. or equivalent

Job description

Role

Senior legal strategist supporting R&D activities across the Americas, primarily U.S., focused on research, early development, clinical operations, and associated regulatory compliance for innovative medicines.

Responsibilities

• provide legal counsel on FDA regulatory requirements, human subject protections, GxP compliance, data sharing, and AI-enabled research
• support integration of acquired assets
• advise on legal risks related to cross-border data exchanges, collaborations, and new business models
• support clinical and biomedical research activities, including privacy, site selection, and data use
• partner with security, regulatory, and other teams on AI ethics and legal frameworks
• review policies and training for compliance.

Requirements

• J.D. or equivalent
• admitted in at least one U.S. jurisdiction
• 8+ years post-bar legal experience in life sciences, preferably biotech/pharma, with expertise in FDA law, clinical development, GxP, and regulatory strategy
• strong analytical, judgment, and cross-functional collaboration skills
• familiarity with emerging technologies, AI, and global legal considerations.

HighValue

focus on U.S. regulatory landscape, clinical development, GxP, data sharing, AI ethics, biotech/pharmaceutical R&D.

WorkSetup

based in Cambridge, MA or East Hanover, NJ, with a minimum of 3 days/week onsite.