Counsel, Clinical Contracting

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:Biomedicines’ clinical programs to move forward efficiently and compliantly—bringing cutting-edge therapeutics to patients faster.

About Generate Biomedicines

We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines.

Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.

At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.