Clinical Trials Partner
OGC (Outside General Counsel LLP) · United States
- Hybrid
- Part-time
- $200,000 / year
- United States
Job highlights
- Lead clinical trial legal agreements for OGC.
- Support biotech and pharma clients' development.
- Navigate complex research regulations.
- Work remotely with experienced legal professionals.
- Provide innovative legal counsel to businesses.
About the role
About Outside GC
Outside GC is the nation's leading partner-only provider of on-demand general counsel services. We are a thriving and expanding virtual law firm offering an innovative approach to legal services for early-stage, growing, and mature businesses. Our team consists of senior business lawyers with substantial in-house and general counsel experience, providing outstanding corporate and IP legal services at a fraction of the cost of traditional options. Clients typically work with one Outside GC lawyer but have access to the entire team for specialized expertise.
Why Attorneys Love Our Team
- Flexibility to work full-time, part-time, and during preferred hours in a fully remote setting.
- High-quality legal engagements.
- Collegiality and camaraderie with experienced and talented colleagues for resource sharing, referrals, and coverage.
- Support from an outstanding team of financial, operations, client relations, and business development professionals.
What You Bring to Our Team
- Experience: A minimum of 10 years in corporate legal practice, including in-house experience as General Counsel or in a similar senior role, plus 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 the 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 the state where you reside/practice.
Our Commitment to Diversity, Equity, and Inclusion
At OGC, we believe that a focus on diversity, equity, and inclusion is integral to hiring exceptional people and creating enduring businesses. We strive to create an organization where every individual is celebrated, heard, valued, and empowered to reach their full potential. We are committed to ensuring OGC is a great place to work for all by creating diverse teams, strengthening our culture of inclusion, and providing equitable opportunities for success. OGC is proud to be an Equal Opportunity and Affirmative Action Employer.
Key skills/competency
- Clinical Trial Agreements
- Contract Research Agreements
- Sponsored Research Agreements
- Biotech Legal
- Pharma Legal
- Life Sciences
- Regulatory Compliance
- HIPAA
- IRB
- General Counsel
Skills & topics
- Clinical Trials Attorney
- Clinical Trial Agreements
- Contract Research
- Sponsored Research
- Biotech Legal
- Pharma Legal
- Life Sciences
- Regulatory Compliance
- HIPAA
- General Counsel
- Remote Attorney
- Legal Services
- Corporate Law
- In-house Counsel
- J.D.
- State Bar
How to get hired
- Tailor your resume: Highlight your 10+ years of corporate legal practice, in-house experience, and specific expertise in clinical trial agreements.
- Showcase life sciences expertise: Emphasize your experience with biotech, pharma, academic research, IRB, HIPAA, and DSAs/DTAs.
- Demonstrate business acumen: Prove your track record as a practical, business-focused, and responsive legal partner.
- Address diversity commitment: Align your application with OGC's focus on diversity, equity, and inclusion.
- Prepare for remote work: Be ready to discuss your experience and suitability for a fully remote, flexible work environment.
Technical preparation
Master clinical trial agreement drafting.,Understand IRB and NIH single IRB policy.,Review HIPAA and human subject regulations.,Study data sharing and de-identification.
Behavioral questions
Describe a complex clinical trial negotiation.,How do you manage multiple stakeholder needs?,Explain your approach to regulatory compliance.,How do you contribute to a remote team?
Frequently asked questions
- What specific types of clinical trial agreements does OGC handle?
- OGC handles a range of clinical trial-related agreements, including clinical trial agreements, contract research agreements (CRAs), and sponsored research agreements, primarily for clients in the biotech, pharma, and academic research sectors.
- What is the required experience for a Clinical Trials Attorney at OGC?
- The role requires at least 10 years of corporate legal practice, including significant in-house experience as a General Counsel or senior legal role, plus 3 years of law firm training. Specialized expertise in clinical trial agreements and life sciences is crucial.
- Is this a remote position with OGC?
- Yes, OGC offers a fully remote team environment, providing flexibility for attorneys to work full-time, part-time, and during preferred hours.
- What kind of legal support does OGC provide to life sciences clients?
- OGC supports life sciences clients through all phases of clinical development, covering vendor and manufacturing agreements, software and data licensing, regulatory infrastructure, and compliance protocols for research institutions.
- What regulatory knowledge is essential for this Clinical Trials Attorney role at OGC?
- Candidates must possess a deep understanding of multi-site research frameworks, NIH’s Single IRB Review Policy, human subject protections, research misconduct, and HIPAA compliance.
- How does OGC ensure a diverse and inclusive workplace for its attorneys?
- OGC is committed to diversity, equity, and inclusion by striving to create an organization where every individual is celebrated, heard, valued, and empowered, fostering diverse teams and an inclusive culture.
- What is the typical client profile for OGC's legal services?
- OGC serves early-stage, growing, and mature businesses, including private and public companies and non-profit organizations, providing them with on-demand general counsel services.
- Does OGC require attorneys to have experience with data sharing agreements?
- Yes, familiarity with the secondary use of clinical trial data, data de-identification, and data sharing agreements (DSAs, DTAs) is a key requirement for this role.