Counsel, Clinical Contracting

Generate Biomedicines•Somerville, MA

5d•$150,000 - $188,000

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 supporting late-phase clinical studies. Reporting to the Senior Counsel (Director), Clinical Contracting, this individual will be part of the Contracts and Legal function and collaborate with Clinical Operations, Finance, Regulatory Affairs, Legal, Clinical Development, CRO partners, and clinical sites. This is a hands-on, execution-focused role involving the review, redlining, and negotiation of agreements using approved templates and fallback positions. The role requires extensive global clinical trial contracting experience, strong attention to detail, and the ability to work in a fast-paced, collaborative environment. Generate:Biomedicines is a clinical-stage generative biology company founded in 2018. It combines machine learning and large-scale experimentation to design proteins with defined biological intent and advance clinical and preclinical programs across multiple disease areas and protein modalities. The company is committed to equal employment opportunity.

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 the end-to-end review, negotiation, and finalization of a high volume of global clinical site agreements, ensuring alignment with internal policies, study timelines, operational strategy, and regulatory requirements.
Draft, review, and negotiate clinical research agreements and documents, including CTAs, MCTAs, CDAs, ICFs, Standard Contractual Clauses, data privacy agreements, IRB/IEC agreements, regulatory documents, IIS contracts, site budgets and payment terms, letters of indemnification, and supporting documentation.
Act as a key liaison between internal stakeholders and external partners, including CROs and clinical sites, and communicate to support alignment and timely issue resolution.
Maintain tracking systems and manage document flow across internal platforms and with CRO partners.
Identify and address bottlenecks to support efficient contract turnaround.
Flag risks, non-standard contract terms, and deviations from approved templates, and collaborate with the Senior Counsel on complex issues and consistent policy application.
Suggest improvements to templates, fallback language, workflows, and tracking systems based on practical insights and stakeholder feedback.