Counsel, Clinical Contracting

The role

This person will manage a high volume of global clinical site agreements and related documents for late-phase clinical studies. They will review, redline, and negotiate agreements and collaborate with stakeholders across Clinical Operations, Finance, Regulatory Affairs, Legal, and Clinical Development.

What you will do

• Lead end-to-end review, negotiation, and finalization of global clinical site agreements.
• Draft, review, and negotiate clinical research agreements including CTAs, MCTAs, CDAs, and ICFs.
• Negotiate site budget documents and payment terms.
• Serve as a liaison between internal stakeholders and external partners like CROs and clinical sites.
• Maintain tracking systems and manage document flow.
• Identify and address bottlenecks in contract turnaround.
• Flag risks, non-standard contract terms, or deviations from approved templates.
• Suggest improvements to templates, fallback language, workflows, and tracking systems.

Required qualifications

• 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.
• JD from an accredited law school.
• Admitted to practice at least one US jurisdiction.

Nice to have

• Prior experience in pharma, biotech, CRO, or academic institutions
• Experience with both US and international clinical site contracting
• Familiarity with regulatory frameworks including ICH-GCP, HIPAA, and GDPR
• Experience working with contract lifecycle management (CLM) systems or similar tools

Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package

Before you apply

• Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates.

About the company

Generate Biomedicines is a clinical-stage generative biology company pioneering the AI revolution in drug design and development. Founded in 2018, the company integrates machine learning with large-scale experimentation to design proteins with defined biological intent.