Candidate Availability
Required and preferred rules are kept separate and reflect the wording in the original posting.
About the Role
You will serve as the dedicated legal partner for clinical development and operations. You will draft, negotiate, and execute clinical research agreements, manage legal and regulatory risks, improve contracting processes, coordinate with cross-functional colleagues, manage outside counsel, and introduce AI tools into the clinical contracting lifecycle.
Requirements
- J.D. or equivalent law degree
- Active U.S. state bar admission in good standing, with Massachusetts Bar admission or eligibility for in-house registration in Massachusetts
- Substantial direct experience structuring, drafting, and negotiating complex clinical trial agreements and related agreements
- Experience in a biotechnology or pharmaceutical in-house legal department or a specialized life sciences law firm
- Expert knowledge of clinical trial execution, CRO outsourcing models, and GCP/ICH regulatory guidelines
- Experience managing a high volume of transactions autonomously
- Knowledge of US, UK, and EU clinical trial regulatory frameworks
- Experience with clinical data rights and intellectual property provisions in computational biology, data-intensive research, or AI-driven platforms
Responsibilities
- Draft, review, negotiate, and execute clinical research agreements
- Serve as the day-to-day legal partner to the Clinical Development team
- Establish and optimize clinical contracting playbooks and template libraries
- Identify, manage, and mitigate legal, regulatory, intellectual property, privacy, and compliance risks
- Collaborate with legal and business operations colleagues on trial governance and data rights
- Manage outside counsel and the clinical transactions legal budget
- Evaluate, pilot, and embed AI technologies in the clinical contracting lifecycle