Counsel, Clinical Contracting

Generate Biomedicines; Somerville (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Generate Biomedicines is seeking a proactive Corporate Counsel, Clinical Contracting to manage a high volume of global clinical site agreements and related documents for late‑phase studies. You will review, redline, and negotiate using approved templates, collaborating with Clinical Operations, Finance, Regulatory Affairs, and CRO partners.

The role requires 5+ years of clinical contracting experience, deep regulatory knowledge, and the ability to thrive in a fast‑paced team.

Qualifications

• 5+ years of clinical contracting experience in biotech/pharma/CRO environments.
• Deep knowledge of clinical site contracts and regulatory support documents.
• Proven track record negotiating with sites, academia, or investigators.
• Ability to redline and finalize contracts efficiently and independently.

Responsibilities

• Lead end‑to‑end review, negotiation, and finalization of global clinical site agreements.
• Draft, review, and negotiate CTAs, MCTAs, CDAs, ICFs, and related documents.
• Coordinate with CROs and internal stakeholders to ensure timely turnaround.
• Flag risks and deviations, enforce template compliance, and resolve issues.
• Suggest template improvements and optimize workflows.

Skills

Clinical contracting

Negotiation

Regulatory knowledge

Cross-functional collaboration

CLM systems

US law license

Education

Juris Doctor (JD)

US bar admission

Tools

Contract CLM systems

Job 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

Cross-functional Collaboration

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.

Why this job:

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:Biomedicin