Director, R&D Legal, Americas
Jobleads-US
Role
Lead legal support for R&D activities in the Americas, primarily U.S., focusing on research, clinical operations, and development units.
Responsibilities
- Provide strategic legal counsel on FDA regulatory requirements, research governance, data sharing, GxP compliance, and emerging tech like AI.
- support integration of acquired assets.
- advise on cross-border data exchanges and collaborations.
- support clinical trial activities including privacy, site selection, and patient engagement.
- partner across legal, regulatory, and business teams to manage legal risks and ensure compliance.
Requirements
- J.D. or equivalent, admitted in at least one U.S. jurisdiction.
- 8+ years' legal experience in life sciences, preferably biotech or pharma, with strong knowledge of FDA law, clinical development, and GxP.
- experience supporting R&D or clinical operations.
- strategic, analytical, and risk assessment skills.
- ability to translate complex legal concepts into practical advice.
- interest in emerging tech and global regulatory landscapes.
High-Value
U.S.-focused, biotech/pharma R&D, clinical operations, GxP, FDA regulation, legal support for AI and data sharing, cross-border collaborations.
Work Setup
based in Cambridge, MA or East Hanover, NJ, with a requirement to be onsite 3x/week.
#J-18808-Ljbffr Jobleads-USVacancy posted 1 day ago
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