Senior Contracts Counsel – Clinical

Role Overview

• Draft, revise, negotiate, and manage a wide range of contracts and documents, including clinical trial agreements, informed consent forms, NDAs, MSAs, CRO Agreements, MTAs, DPAs, consulting/professional services agreements, SOWs, amendments, change orders and various other vendor agreements.
• Work closely with various internal clients to ensure contracts accurately convey desired terms, while minimizing risk.
• Ensure efficient negotiation and project management of the contract life cycle in support of Clinical Development timelines.
• Identify and be able to communicate risks appropriately to internal stakeholders and provide guidance for resolution.
• Ensure continuity and improvement in the quality, efficiency, and effectiveness of contracting systems, processes, and procedures, including the development of templates, fallback language, negotiation guidelines, and escalation protocols, in collaboration with the AGC.
• Act as the primary legal point of contact for the Clinical Development organization, including Clinical Operations, Regulatory, Quality, Med Affairs, Biostats, Safety, and Translational Sciences
• Identify and appropriately manage contract-related risks, including subject injury, data privacy, indemnification, and IP provisions
• Ensure alignment of clinical contracts with applicable regulatory frameworks
• In collaboration with the Head of Procurement, support contractual engagement of CROs and other clinical vendors
• Address country-specific contracting and global clinical trial execution

Requirements

• JD degree, with regulatory law experience (e.g., clinical, quality, GxP, and data protection)
• Admitted to a state bar in good standing.
• 8+ years of relevant transactional experience, preferably in-house experience in a life sciences company or a contract research organization, including clinical trial contracting. Experience with Investigative Site budgets is a plus.
• Demonstrated ability to achieve positive results through influence, negotiation, and organizational change.
• Strong experience in reviewing and advising on the legal consequence of contract terms for multiple different functions.
• Experience with Ironclad.
• Proven experience in working well independently and in a team environment.
• Must be efficient, detail-oriented, and have strong organizational skills.
• Ability to handle multiple tasks simultaneously and with the ability to pivot on short time frames while delivering quality advice and outcomes.
• Must have excellent interpersonal communication skills and partner well cross functionally.
• Ability to adapt quickly to a fast pace, dynamic culture with evolving needs.