Kyverna Therapeutics
Executive Director/VP, Clinical Operations
Kyverna Therapeutics, Emeryville, California, United States, 94608
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 Executive Director/VP of Clinical Operations will help advance the mission to free patients from the siege of autoimmune disease. The ideal candidate will contribute to our goals of navigating what is next in synthetic biology, immunology and cell engineering while living our core values: bring intellectual humility, elevate each other, and stay true to why.
Responsibilities
Lead the operational strategy and delivery of a product within the Clinical Operations team. Provide strategic view on operational planning, direction and delivery aligned to corporate goals. Provide strong input to the Product Core Team in all aspects of ideation, planning, and delivery of clinical programs. Drive significant internal and external relationships (CRO, Academic Partners, Advocacy Groups) for the benefit of the programs. Be a cross functional expert in the planning and delivery of clinical programs to ensure that the Kyverna development work is cohesive and efficient. Hire, build and develop high performing clinical operations teams. Drive and manage their individual and collective performance. Deliver integrated program planning for enrollment, timelines, and costs in collaboration with cross functional team, and present plan and significant updates to governance. Understand enrollment dynamics in autoimmune, neurology, rheumatology and rare disease indications as required. Design, advocate for, and implement effective recruitment strategies. Ensure demand model for CAR-T manufacturing with Technical Operations is established for the product and is collaboratively forecast for business planning. Lead initiatives outside of clinical trial delivery to build and improve the capability of the R&D organization in response to evolving business needs. Serve as a role model to Clinical Operations, and extended cross functional team, in actions around problem identification, cross functional collaboration and implementation of planned resolutions. Provide input on the development of protocols, Case Report Forms, Clinical Study Reports, and regulatory submissions. Demonstrate to the Clinical Operations, and extended cross functional team, appropriate risk identification, analysis, and resolution skills in accordance with ICH (International Council for Harmonization), GCP (Good Clinical Practices), and other contemporary regulatory frameworks.
Requirements
Bachelor’s Degree in life sciences/healthcare is required. Advanced degree is preferred. At least 16 years of pharmaceutical/biotech/CRO clinical research operations experience in Phase I-IV studies. Preferred experience in complex autoimmune disorders, rheumatology, neurology, complex rare diseases, or cell therapy. Problem solving in challenging clinical studies required. Working knowledge of GCP/ICH, GDPR (General Data Protection Regulation), clinical trial design, regulatory, and clinical development processes. At least 12 years of line management responsibility and knowledge of performance management best practices. Self-starter, with strong ability to communicate and establish effective working relationships with internal leadership, CROs, leadership teams, Investigators, and clinical development partners. Excellent influencing, negotiation, problem-solving, and project management skills. Travel 20% required.
Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other legally protected status. EOE/AA/Vets
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Responsibilities
Lead the operational strategy and delivery of a product within the Clinical Operations team. Provide strategic view on operational planning, direction and delivery aligned to corporate goals. Provide strong input to the Product Core Team in all aspects of ideation, planning, and delivery of clinical programs. Drive significant internal and external relationships (CRO, Academic Partners, Advocacy Groups) for the benefit of the programs. Be a cross functional expert in the planning and delivery of clinical programs to ensure that the Kyverna development work is cohesive and efficient. Hire, build and develop high performing clinical operations teams. Drive and manage their individual and collective performance. Deliver integrated program planning for enrollment, timelines, and costs in collaboration with cross functional team, and present plan and significant updates to governance. Understand enrollment dynamics in autoimmune, neurology, rheumatology and rare disease indications as required. Design, advocate for, and implement effective recruitment strategies. Ensure demand model for CAR-T manufacturing with Technical Operations is established for the product and is collaboratively forecast for business planning. Lead initiatives outside of clinical trial delivery to build and improve the capability of the R&D organization in response to evolving business needs. Serve as a role model to Clinical Operations, and extended cross functional team, in actions around problem identification, cross functional collaboration and implementation of planned resolutions. Provide input on the development of protocols, Case Report Forms, Clinical Study Reports, and regulatory submissions. Demonstrate to the Clinical Operations, and extended cross functional team, appropriate risk identification, analysis, and resolution skills in accordance with ICH (International Council for Harmonization), GCP (Good Clinical Practices), and other contemporary regulatory frameworks.
Requirements
Bachelor’s Degree in life sciences/healthcare is required. Advanced degree is preferred. At least 16 years of pharmaceutical/biotech/CRO clinical research operations experience in Phase I-IV studies. Preferred experience in complex autoimmune disorders, rheumatology, neurology, complex rare diseases, or cell therapy. Problem solving in challenging clinical studies required. Working knowledge of GCP/ICH, GDPR (General Data Protection Regulation), clinical trial design, regulatory, and clinical development processes. At least 12 years of line management responsibility and knowledge of performance management best practices. Self-starter, with strong ability to communicate and establish effective working relationships with internal leadership, CROs, leadership teams, Investigators, and clinical development partners. Excellent influencing, negotiation, problem-solving, and project management skills. Travel 20% required.
Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other legally protected status. EOE/AA/Vets
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