Clinical Trials Partner

Summary

Join Outside GC, a leading virtual law firm, and become a crucial part of our team. We offer flexibility to work remotely, full-time or part-time, with high-quality legal engagements. Collaborate with experienced colleagues in a supportive environment. Our team provides exceptional legal services to clients, supported by professionals in finance, operations, client relations, and business development. We are committed to diversity, equity, and inclusion, fostering a workplace where every individual is valued and empowered. We are an Equal Opportunity and Affirmative Action Employer.

Requirements

• Experience: At least 10+ years of corporate legal practice, including experience as an in-house attorney, serving as a General Counsel and/or in another senior in-house legal role, and 3+ years of law firm training
• Specialized Expertise: Significant experience drafting and negotiating clinical trial agreements, contract research agreements, and sponsored research agreements for biotech, pharma, and academic research institutions
• Proven track record supporting life sciences clients through all phases of clinical development, including vendor and manufacturing agreements, software and data licensing, and regulatory infrastructure
• Deep understanding of multi-site research frameworks, including IRB reliance arrangements and compliance with NIH’s Single IRB Review Policy
• Skilled in navigating complex regulatory environments involving human subject protections, research misconduct, and HIPAA compliance
• Experience working with academic medical centers, hospitals, and federal research agencies to design and implement streamlined, scalable contracting and compliance protocols
• Familiarity with secondary use of clinical trial data, data de-identification, and data sharing agreements (DSAs, DTAs)
• Demonstrated success as a practical, business-focused, and responsive legal partner
• J.D. from a nationally accredited law school
• State bar membership in state where reside/practice

Benefits

Flexibility to work full-time, part-time, and during preferred times as part of a fully remote team