Clinical Trials Partner

WHO WE ARE

Outside GC, the nation's leading partner-only provider of on-demand general counsel services, is a thriving and expanding virtual law firm offering an innovative approach to legal services for early-stage, growing, and mature businesses. With a team of senior business lawyers with substantial in-house and general counsel experience, Outside GC provides private and public companies and non-profit organizations with outstanding corporate and IP legal services as needed at a fraction of the cost of either hiring a full-time general counsel or relying exclusively on law firm counsel. Clients typically develop a working relationship with one Outside GC lawyer and have access to the whole team for specific subject-matter experience.

WHY ATTORNEYS LOVE OUR TEAM

• Flexibility to work full-time, part-time, and during preferred times as part of a fully remote team
• High-quality legal engagements
• The collegiality and camaraderie of highly experienced and talented colleagues to share resources, referrals, and coverage
• The support of an outstanding team of financial, operations, client relations and business development professionals to facilitate the delivery of exceptional, pragmatic, and cost-effective legal services to our clients

YOU BRING TO OUR TEAM

• 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