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 Counsel, Clinical Contracting to manage a high volume of global clinical site agreements and related legal documents in support of late-phase (Phase II-III) studies. Reporting to the Senior Counsel, Clinical Contracting, this individual will play a key executional role within the Legal and Contracts team and will collaborate cross-functionally with stakeholders in Clinical Operations, Finance, Regulatory, Legal, Clinical Development, and external CRO partners.

This role is ideal for someone who thrives in a fast-paced, highly collaborative environment and is comfortable balancing process efficiency with strong contract execution and stakeholder engagement. This is a hands-on position that includes contract review, redlining, and negotiation, primarily against internally approved templates and fallback positions.

Here's how you will contribute:

Contract Execution & Negotiation
Lead the end-to-end review and negotiation of global clinical site agreements (CTAs), and related documents, working from pre-approved templates and legal positions while ensuring alignment with trial timelines 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) ? re
  • iew 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

Stakeholder Engagement
Serve as a trusted partner to Legal, Clinical Operations, Finance, Clinical Development, Regulatory, and CRO teams. Ensure alignment on contracting strategy, risk tolerance, and business priorities.

Contracting Process Management
Maintain contracting trackers and manage document flow across internal systems and CRO partners. Proactively follow up to minimize bottlenecks and keep contracts moving forward efficiently

Escalation & Risk Awareness
Identify and elevate risk-related issues and deviations from approved templates or legal guidance. Partner with Senior Counsel and Deputy General Counsel to resolve challenges and apply consistent business judgment.

Cross-Functional Communication
Communicate regularly with internal teams and external sites or CROs to manage timelines, expectations, and deliverables. Participate in study kickoff meetings and CRO onboarding discussions when needed.

Continuous Improvement
Recommend improvements to templates, fallback language, and internal processes based on observed patterns, inefficiencies, or stakeholder feedback.

The Ideal Candidate will have:

• 5 - 8+ years of relevant experience in clinical contracting within a biotechnology, pharmaceutical, or CRO environment.
• Strong understanding of the structure and key provisions of CTAs, and associated contracts and regulatory documents.
• Experience negotiating directly with clinical sites, academic institutions, and/or investigators.
• Ability to review and redline contracts with precision and speed.
• 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

• JD strongly preferred, with legal/paralegal training in a relevant industry (e.g. pharma, biotech, CRO, or academic institutions).
• Experience with US and international clinical site contracting.
• Familiarity with global site contracting norms, and clinical trial regulatory frameworks (ICH-GCP, HIPAA, GDPR).
• Experience working with contract lifecycle management (CLM) systems.

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. You'll 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 biomedicine?where your legal expertise fuels groundbreaking science.

#LI-KD1

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 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.