Counsel, Clinical Contracting (Senior Manager)

About Generate:Biomedicines

Generate:Biomedicines is a new kind of therapeutics company existing at the intersection of machine learning biological engineering and medicine pioneering Generative Biology to create breakthrough medicines where novel therapeutics are computationally generated instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions with an outsized opportunity for patients in need. We are seeking collaborative relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 millionin funding providing the resources to rapidly scale the organization. The Company has offices in Somerville and

Andover Massachusetts with 300 employees.

The Role:

We are seeking a proactive and detail-oriented Senior Manager/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 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 clinical trial contracting strong attention to detail and an ability to thrive in a fast-paced collaborative environment.

Heres 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 Site Agreements (MSAs)
  • Confidentiality/Non-Disclosure Agreements (CDAs)
  • Informed Consent Forms (ICFs)
  • Review for alignment with CTA provisions
  • IRB/IEC agreements
  • 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:

• 4-6 years of relevant experience in contracting. Contracting within a biotechnology pharmaceutical or CRO environment particularly clinical contracting preferred.
• 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.

Preferred Qualifications

• Bachelors and JD degree required.
• 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 Role
This position is ideal for a clinical contracting professional who enjoys balancing precision with execution speed. Youll play a critical role in
enabling Generate:Biomedicines clinical programs to move forward efficiently and compliantlybringing cutting-edge therapeutics to patients faster.

Location: Somerville MA (Hybrid-onsite minimum 3-4 days per week)

Why Join Us

This role offers the opportunity to directly impact the success of global clinical trials through high-value legal execution and operational excellence. Youll collaborate with cross-functional teams who are as driven by innovation and precision as you are all within a supportive fast-paced environment. Join us and help accelerate the future of biomedicinewhere your legal expertise fuels groundbreaking science.

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Equal Opportunity Employer Statement
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 Companys 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.