Director, R&D Legal, Americas

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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.

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Vacancy posted 2 days ago

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