Senior Counsel, Clinical Contracting (Director)

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 million in 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 highly experienced and strategic Senior Counsel, Clinical Contracting – Legal & Regulatory to lead clinical contracting efforts across a portfolio of late-phase (Phase II-III) clinical trials. This role will be responsible for driving the negotiation and execution of a wide range of clinical trial agreements, and for advising internal stakeholders on contracting strategy, risk mitigation, and regulatory considerations.

While the vast majority of this role (~80–90%) will be focused on transactional clinical contracts, the ideal candidate will also contribute in a strategic legal advisory capacity (~10%), supporting the General Counsel, Clinical Operations, and Tech Ops teams on matters of regulatory law, including quality and compliance.

A JD with regulatory law experience is strongly preferred.

Here's how you will contribute:

Contract Drafting and Negotiation

• Lead hands-on drafting, negotiation, and execution of a wide array of clinical agreements, including CTAs, MCTAs, CRO agreements, CDAs, SOWs, ICFs, IRB/IEC agreements, DPAs, MTAs, and more.
• Ensure efficient, high-quality, and risk-aware contracting support for late-phase global trials.

Cross-Functional Legal Collaboration

• Act as the primary legal point of contact for Clinical Operations, Regulatory Affairs, Quality, and Clinical Development teams regarding clinical contract terms and structures.
• Provide regulatory legal guidance to relevant teams on Clinical, Quality, Regulatory Affairs, and related issues as needed.

Regulatory and Risk Management Support

• Identify and manage contract-related risks including subject injury, data privacy (e.g., GDPR, HIPAA), indemnification, and IP provisions.
• Support alignment of clinical contracts with applicable regulatory frameworks (FDA, ICH-GCP, etc.).

Vendor and Global Trial Support

• Support contractual engagement of CROs and clinical vendors; define scopes, KPIs, and timelines in close coordination with operational leads.
• Address country-specific contracting and legal challenges in global clinical trial execution.

Process Optimization

• Develop and manage contract templates, fallback language, negotiation playbooks, and escalations protocols.
• Track and analyze key metrics (e.g., cycle times, activation delays), and implement process improvements.

Escalation and Strategic Resolution

• Serve as escalation point for high-complexity negotiations and institutional counterparties; collaborate with executive stakeholders and legal advisors to resolve disputes.

The Ideal Candidate will have:

• 10+ years of relevant experience in clinical trial contracting and legal negotiation, ideally within biotech, pharma, or CRO settings.
• JD strongly preferred, especially with regulatory law experience (e.g., clinical quality, GxP, data protection).
• Proven ability to lead clinical contracting functions and support late-phase (Phase II-III) global studies.
• Collaborative, pragmatic and business-minded approach with strong communication and interpersonal skills
• Experience working with global sites and understanding international legal considerations in clinical trials is a plus.

Preferred Attributes

• Strong communication and influence skills across technical and non-technical audiences.
• Demons