Counsel, Clinical Contracting

Generate Biomedicines•Somerville, MA

About The Position

Generate:Biomedicines is seeking a proactive, 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 is a hands-on, execution-focused role within the Contracts and Legal function. The counsel will collaborate with Clinical Operations, Finance, Regulatory Affairs, Legal, Clinical Development, and external CRO partners, reviewing, redlining, and negotiating agreements using approved templates and fallback positions. The role involves leading the end-to-end negotiation and finalization of clinical site agreements; drafting, reviewing, and negotiating clinical research agreements and supporting documents; maintaining document flow and tracking systems; and identifying contract risks, deviations, and process bottlenecks. The counsel will help ensure contracts align with internal policies, study timelines, operational strategy, and regulatory requirements, while contributing practical suggestions for improving templates, workflows, fallback language, and tracking systems. This position supports Generate:Biomedicines’ clinical programs and its work as a clinical-stage generative biology company developing protein-based medicines. Compensation includes a base salary range of $150,000–$188,000 per year, eligibility for an annual bonus and equity compensation, and a competitive benefits package.

Requirements

At least 5 years of relevant clinical contracting experience within a biotechnology, pharmaceutical, or CRO environment.
Deep working knowledge of clinical site contracts and regulatory support documents.
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 and with minimal supervision.
Excellent interpersonal and communication skills, with the ability to build relationships across departments and with external partners.
Juris Doctor (JD) from an accredited law school.
Admission to practice in at least one U.S. jurisdiction.

Nice To Haves

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

Responsibilities

Lead end-to-end review, negotiation, and finalization of a high volume of global clinical site agreements.
Ensure agreements align with internal policies, study timelines, operational strategy, and regulatory requirements.
Draft, review, and negotiate Clinical Trial Agreements, Master Clinical Trial Agreements, confidentiality and non-disclosure agreements, informed consent forms, Standard Contractual Clauses and data privacy agreements, IRB/IEC agreements, regulatory documents, Investigator-Initiated Study 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 with stakeholders to support transparency, alignment, and timely issue resolution.
Maintain tracking systems and manage document flow across internal platforms and with CRO partners.
Identify and address workflow bottlenecks to support efficient contract turnaround.
Flag risks, non-standard contract terms, and deviations from approved templates.
Collaborate with the Senior Counsel to resolve complex issues and ensure consistent application of policy.
Suggest improvements to templates, fallback language, workflows, and tracking systems based on practical insights and stakeholder feedback.