Sr. Contracts Counsel - Clinical
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.
Title: Sr. Contracts Counsel
Reports to: Associate General Counsel
Location: Remote (West coast hours preferred)
Kyverna is seeking an in-house Sr. Contracts Counsel, who will be an integral member of the Legal Department. The Sr. Contracts Counsel will contribute in a strategic legal advisory capacity, supporting the AGC, and the Clinical Development team with contract negotiation, as well as assisting with the development of contracting standards, processes, and strategy in support of the Company’s strategic objectives. In addition, the Sr. Contracts Counsel will ensure contracts adhere to company policy and help develop standard templates. While this role will collaborate closely the Clinical Development organization, it will require cross-functional collaboration with team members from all functions of the company.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
Qualifications
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.
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.
Title: Sr. Contracts Counsel
Reports to: Associate General Counsel
Location: Remote (West coast hours preferred)
Kyverna is seeking an in-house Sr. Contracts Counsel, who will be an integral member of the Legal Department. The Sr. Contracts Counsel will contribute in a strategic legal advisory capacity, supporting the AGC, and the Clinical Development team with contract negotiation, as well as assisting with the development of contracting standards, processes, and strategy in support of the Company’s strategic objectives. In addition, the Sr. Contracts Counsel will ensure contracts adhere to company policy and help develop standard templates. While this role will collaborate closely the Clinical Development organization, it will require cross-functional collaboration with team members from all functions of the company.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
Qualifications
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.
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.