Head of Global Safety and Pharmacovigilance

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated The Head of Global Safety and Pharmacovigilance is being established at Kyverna to be the nucleus of the future Patient Safety organization. This is a global role responsible for providing dynamic leadership, strategic direction and governance of all Patient Safety Activities at Kyverna, service providers and partners.  The mission will be adjusted as the organization matures. This position reports to the CMO and leads the Safety Governance Board to take decisions on the safety profile and benefit-risk of Kyverna products and is a member of the appropriate leadership teams and quality boards to represent Patient Safety, while also inputting into aspects of the overall R&D strategy.  Partnerships with key stakeholders will be paramount.  This includes internal stakeholders such as Clinical Development, Medical Affairs, Regulatory Affairs, Compliance and Commercial as well as external stakeholders, which includes investigators, service providers, consultants and various regulatory bodies around the world.   The Head of Global Safety and Pharmacovigilance will oversee effective cross-functional and cross-regional alignment to achieve the business objectives of Patient Safety and ensure that patient wellbeing is the primary consideration in all Kyverna endeavors.  This position requires a seasoned leader to oversee all aspects of Patient Safety with the following main mission: Safety Organization: Build the Kyverna Patient Safety organization organically, in line with the evolution of the company, and in collaboration with internal partner functions and external service providers, with a focus on scientific expertise, compliance and global reach. Safety Data: Develop a comprehensive view of safety data to facilitate close to real time analysis of the safety profile of Kyverna products, by physically consolidating ICSR into a unified safety database (the database itself being outsourced) and by having appropriate visibility to safety data in clinical databases and other uses. Safety Strategy: Create a scientifically driven safety and risk management/risk minimization strategy for Kyverna products, using a translational safety approach, and implement the strategy in all development and commercialization activities.

Responsibilities:

• Accountable for the overall strategic leadership of the emerging Patient Safety Department, and of Patient Safety activities across the company. 
• Ensuring effective safety decision-making throughout the life-cycles of all Kyverna medicinal products.
• Creating a scientifically driven safety strategy for Kyverna products, using a translational safety approach, taking into account scientific principles, prior research and development results, literature, competitive intelligence, and disease area principles.
• Actively identify and monitor safety signals and safety issues based on holistic analysis of all available information, in line with the safety strategy, detect signals that are not anticipated.
• Lead the workup of current and potential safety issue and provide independent medical and regulatory judgments on critical, time sensitive Patient Safety and compliance matters.
• Chair the Safety Governance Board where safety decisions and actions are endorsed in a cross- functional setting.
• Develop risk management and risk minimization strategies and implement them in the development process, compassionate use programs, and regulatory filings.
• Ensure that safety strategies and decisions are cascaded to all relevant stakeholders and implemented in protocols, IB, IC and other regulatory and information material.
• Take a leadership role in the management of a safety related crises.

> Patient Safety in clinical development and compassionate use programs

• Liaise with clinical development teams, compassionate use participants and service providers to establish comprehensive and timely access to relevant safety data.
• Ensure that a comprehensive safety database for ICSR is in place and all expedited and periodic reporting requirements are met.
• Ensure that assessment of SAE is timely and robust, including definitions of adverse events of special interest with respective follow up procedures and adjudication committees.
• Work with clinical teams and provide input into development plans, study protocols, CRF, IB, IC p