Responsibilities
- 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
Team
Structure: Legal Department. Reports to: Associate General Counsel
Additional Information
- The national base salary range for candidates for this position is $200K to $235K annually.
- This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors that may include but are not limited to quality and length of experience, education, geographic location and alignment with market data.
