Clinical Trials Partner

At OGC, we are the nation’s leading partner-only provider of on-demand general counsel services. Our team of senior business lawyers offers outstanding corporate and IP legal services to private and public companies and non-profit organizations.

About the role

• Flexible work schedule, including full-time, part-time, and preferred hours, as part of a fully remote team
• High-quality legal engagements
• A supportive environment with a collegial and talented team of colleagues who share resources, referrals, and coverage
• Access to an outstanding team of financial, operations, client relations, and business development professionals to facilitate exceptional, pragmatic, and cost-effective legal services

Responsibilities

• Experience drafting and negotiating clinical trial agreements, contract research agreements, and sponsored research agreements for biotech, pharma, and academic research institutions
• Supporting life sciences clients through all phases of clinical development, including vendor and manufacturing agreements, software and data licensing, and regulatory infrastructure
• Understanding and navigating complex regulatory environments involving human subject protections, research misconduct, and HIPAA compliance
• Navigating multi-site research frameworks, including IRB reliance arrangements and compliance with NIH’s Single IRB Review Policy
• 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)
• Practical, business-focused, and responsive legal partner

Requirements

• 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
• 3+ years of law firm training
• 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

Qualifications

• J.D. from a nationally accredited law school
• State bar membership in state where reside/practice

Skills

• Diversity, equity, and inclusion

Benefits

• Equal Opportunity and Affirmative Action Employer

Pay

Compensation is commensurate with experience.

Schedule

Flexible work schedule, including full-time, part-time, and preferred hours, as part of a fully remote team.