Legal Counsel

Role: Mid-level legal counsel supporting clinical trial operations within a biopharma setting, primarily focusing on drafting, reviewing, and negotiating clinical trial agreements and related documentation. Responsibilities include leading clinical trial contracting processes, managing relationships with CROs and clinical sites, and enhancing the company's Contract Lifecycle Management (CLM) platform through process improvements and standardization, including AI integration. The role involves advising internal teams on legal strategies, mitigating compliance risks, and overseeing external counsel. Qualifications: Juris Doctor from an ABA-accredited law school, licensed to practice, with 5-8 years of experience supporting clinical trials in biotech, pharma, or law firms. Essential skills encompass expertise in clinical trial contracts, CRO/vendor negotiations, and a solid understanding of FDA, GCP, and international regulatory requirements. Experience with global clinical trial operations, data privacy laws, and CLM systems is preferred. High-value specifics: Focus on global clinical trial support involving R&D agreements, confidentiality, informed consent, and data governance, with an emphasis on risk-based guidance for compliant, efficient trial conduct. Collaboration: Works closely with clinical operations, legal, and compliance teams, reporting to the Assistant General Counsel. Work setup: Based in Boston, hybrid work model, with some travel expected.