Global Clinical Contracts Counsel for High-Impact Studies

Generate Biomedicines; Somerville (MA); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Clinical contracting

Negotiation

Regulatory knowledge

Cross-functional collaboration

CLM systems

US law license

Formation

Juris Doctor (JD)

US bar admission

Outils

Contract CLM systems

Description du poste

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.