Description:
The Role:We are seeking a proactive and detail-oriented Corporate Counsel, Clinical Contracting to manage a high volume of global clinical site agreements and related documents in support of late-phase clinical studies. Reporting to the Senior Counsel (Director), Clinical Contracting, this individual will be a key member of the Contracts and Legal function and collaborate closely with stakeholders across Clinical Operations, Finance, Regulatory Affairs, Legal, Clinical Development, and external CRO partners.
This is a hands-on, execution-focused role that includes reviewing, redlining, and negotiating agreements based on approved templates and fallback positions. The ideal candidate brings extensive experience in global clinical trial contracting, strong attention to detail, and an ability to thrive in a fast-paced, collaborative environment.
Here's how you will contribute:
Contract Execution & Negotiation
Lead the end-to-end review, negotiation, and finalization of a high volume of global clinical site agreements. Ensure alignment with internal policies, study timelines, operational strategy, and regulatory requirements.
Document Scope
Draft, review, and negotiate a wide range of clinical research-related agreements and documents, including:
- Clinical Trial Agreements (CTAs)
- Master Clinical Trial Agreements (MCTAs)
- Confidentiality/Non-Disclosure Agreements (CDAs)
- Informed Consent Forms (ICFs)
- Standard Contractual Clauses and Data Privacy Agreements
- IRB/IEC agreements
- Regulatory documents
- Investigator-Initiated Study (IIS) contracts
- Site budget documents and payment terms
- Letters of indemnification, and other supporting documentation
Serve as a Key liaison between internal stakeholders and external partners (including CROs and clinical sites). Communicate clearly with stakeholders to ensure transparency, alignment, and timely issue resolution.
Process Management
Maintain tracking systems and manage document flow across internal platforms and with CRO partners. Proactively identify and address bottlenecks, ensuring efficient contract turnaround.
Escalation & Risk Awareness
Flag risks, non-standard contract terms, or deviations from approved templates. Collaborate with the Senior Counsel to resolve complex issues and ensure consistent application of policy.
Continuous Improvement
Suggest improvements to templates, fallback language, workflows, and tracking systems based on practical insights and stakeholder feedback.
The ideal candidate will have:
- 5+ years of relevant experience in clinical contracting within a biotechnology, pharmaceutical, or CRO environment.
- Deep working knowledge of clinical site contracts and regulatory support documents.
- Proven experience negotiating directly with clinical sites, academic institutions, and/or investigators.
- Ability to redline and finalize contracts efficiently and independently.
- Demonstrated ability to manage high-volume contracting workflows under tight timelines.
- Proven ability to manage high-volume workflows with minimal supervision.
- Excellent interpersonal and communication skills with the ability to build relationships across departments and external partners.
- JD from an accredited law school and admitted to practice at least one US jurisdiction.
Preferred Qualifications:
- Prior experience in pharma, biotech, CRO, or academic institutions is preferred.
- Experience with both US and international clinical site contracting is a plus.
- Familiarity with regulatory frameworks including ICH-GCP, HIPAA, and GDPR.
- Experience working with contract lifecycle management (CLM) systems or similar tools.
The ideal candidate will have:
- 5+ years of relevant experience in clinical contracting within a biotechnology, pharmaceutical, or CRO environment.
- Deep working knowledge of clinical site contracts and regulatory support documents.
- Proven experience negotiating directly with clinical sites, academic institutions, and/or investigators.
- Ability to redline and finalize contracts efficiently and independently.
- Demonstrated ability to manage high-volume contracting workflows under tight timelines.
- Proven ability to manage high-volume workflows with minimal supervision.
- Excellent interpersonal and communication skills with the ability to build relationships across departments and external partners.
- JD from an accredited law school and admitted to practice at least one US jurisdiction.
Preferred Qualifications:
- Prior experience in pharma, biotech, CRO, or academic institutions is preferred.
- Experience with both US and international clinical site contracting is a plus.
- Familiarity with regulatory frameworks including ICH-GCP, HIPAA, and GDPR.
- Experience working with contract lifecycle management (CLM) systems or similar tools.
This position is ideal for a clinical contracting professional who enjoys balancing precision with execution speed. You'll play a critical role in enabling Generate:Biomedicines' clinical programs to move forward efficiently and compliantly—bringing cutting-edge therapeutics to patients faster.
