Overview
This Senior Counsel role serves as the primary legal advisor for clinical contracting matters and provides legal support across clinical development, medical affairs, and research and development activities, with a focus on the U.S. market.
The position leads the legal drafting, review, and negotiation of complex clinical agreements, including CRO and clinical trial site agreements, in partnership with Clinical Operations. As the organization grows and programs advance, the scope may expand to support additional contracting needs.
Responsibilities
- Lead the legal drafting, review, and negotiation of agreements supporting clinical development activities, including CRO agreements, Clinical Trial Agreements (CTAs), site agreements, MSAs, SOWs, and vendor agreements
- Act as the primary legal partner to the clinical organization on U.S.-related contracting matters; provide practical legal advice that supports clinical program objectives while appropriately managing risks
- Partner with Clinical Operations throughout contract development and negotiation, with Legal leading legal terms and Clinical Operations contributing to and leading, as appropriate, non-legal and operational components
- Ensure scopes of work, deliverables, milestones, timelines, budgets, payment schedules, resourcing, performance expectations, and other operational requirements are accurately reflected in agreements
- Lead legal negotiations with CROs, clinical sites, academic medical centers, laboratories, vendors, consultants, and other third parties
- Advise on contractual matters including intellectual property, indemnification, limitation of liability, confidentiality, publication rights, data ownership and use, compliance, insurance, termination, warranties, privacy, and other material provisions
- Partner with the clinical organization on amendments, change orders, scope changes, vendor performance matters, and contractual issues arising throughout clinical study execution
- Collaborate cross-functionally to ensure appropriate business and functional requirements are incorporated into agreements
- Identify opportunities to streamline contracting processes, improve consistency, and reduce contract cycle times
- Coordinate with outside counsel and other subject matter experts on specialized legal matters, as appropriate
- Support additional corporate contracting matters, as needed
Requirements
- Strong knowledge of clinical contracting and the legal and business considerations associated with clinical drug development
- Excellent contract drafting and negotiation skills, including experience with CRO, clinical site, vendor, and other clinical agreements
- Sound legal and business judgment, with the ability to assess risk and provide practical, solution-oriented advice
- Ability to independently lead complex negotiations and advise senior business stakeholders
- Ability to develop clinical contract templates, contracting standards, and processes
- Strong attention to detail and commitment to accuracy
- Excellent organizational and record-management skills
- Ability to manage multiple contracts, deadlines, and priorities simultaneously
- Ability to work collaboratively across functions in a small, evolving organization
- Proficiency with Microsoft Office and electronic contract management systems
Education and Licenses
- Bachelor’s degree in Legal, Business Administration, Life Sciences, or a related field
- Juris Doctor (JD) from an accredited law school
- 8+ years of relevant legal experience with significant experience in the pharmaceutical, biotechnology, or life sciences industry
Preferred Qualifications
- Significant experience drafting and negotiating complex clinical agreements, including CRO and clinical trial/site agreements
- Experience within a large pharmaceutical organization, biotechnology/life sciences company, and/or private practice supporting life sciences clients strongly preferred
- Commercial contracting experience within the pharmaceutical organization, biotechnology/life sciences company, and/or private practice supporting life sciences clients
Location
Focus is on the U.S. market. The organization is headquartered in France.