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 At OGC, we believe a focus on diversity, equity, and inclusion is integral to hiring exceptional people and creating enduring businesses. To inspire growth at our firm and throughout our portfolio, we strive to create an organization where every individual is celebrated, heard, valued, and empowered to reach their full potential. We will continuously look for ways to improve and evolve in our ever-changing world and we are committed to ensuring OGC is one of the best places to work for all by creating diverse teams, strengthening our culture of inclusion, and giving everyone an equitable opportunity to succeed. OGC is proud to be an Equal Opportunity and Affirmative Action Employer. We evaluate qualified applicants without regard to race, color, religion (including religious dress and grooming practices), sex (including pregnancy, childbirth and related medical conditions, breastfeeding, and conditions related to breastfeeding), gender, gender identity, gender expression, national origin, ancestry, age (40 or over), physical or medical disability, medical condition, marital status, registered domestic partner status, sexual orientation, genetic information, military and/or veteran status, or any other basis prohibited by applicable state or federal law.