Note: The job is a remote job and is open to candidates in USA. Outside GC is the nation’s leading partner-only provider of on-demand general counsel services, offering innovative legal services for various businesses. The role of Clinical Trials Partner involves extensive legal expertise in clinical trials and life sciences, providing legal support and guidance throughout the clinical development process.
Responsibilities
- 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
- Navigating complex regulatory environments involving human subject protections, research misconduct, and HIPAA compliance
- Working with academic medical centers, hospitals, and federal research agencies to design and implement streamlined, scalable contracting and compliance protocols
Skills
- 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
- 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
- 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
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