Full-Time Contracts Counsel

• Draft, review, and negotiate a wide range of clinical research agreements, including but not limited to:
  • Clinical Trial Agreements (CTAs)
  • Informed Consent Forms (ICFs)
  • Confidentiality Agreements (CDAs)
  • Collaboration and Investigator-Initiated Study Agreements
• Advise internal stakeholders on contract terms, risk mitigation, and compliance with applicable laws and industry standards (e.g., GCP, FDA, GDPR, HIPAA).
• Partner closely with Clinical Operations and R&D teams to support clinical study execution and vendor relationships.
• Provide practical, business-focused legal advice across the clinical and research contracting lifecycle.
• Support development and refinement of contract templates and policies and procedures related to contracting.
• Collaborate with Legal and Compliance colleagues on other ad hoc matters as needed.

• J.D. from an accredited U.S. law school; admitted to practice in at least one U.S. jurisdiction.
• 4–6 years of relevant legal experience, with a significant focus on clinical contracting in the biotech or pharmaceutical industry.
• Direct experience supporting Clinical Operations, R&D, and/or Regulatory Affairs teams.
• Strong working knowledge of applicable laws and regulations governing clinical research.
• Excellent negotiation, drafting, and communication skills.
• Ability to manage multiple priorities in a fast-paced, evolving environment.
• Team player with a collaborative mindset and a commitment to delivering practical solutions.

• In-house experience at a biotech or pharmaceutical company, especially in rare disease or clinical-stage environments.
• Familiarity with ex-U.S. clinical trial contracting and international regulations.

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