Senior Director, CMC Regulatory Affairs

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. Kyverna is recruiting a Senior Director CMC Regulatory Affairs to join the Regulatory Affairs and Quality organization to advance its mission to transform the treatment of autoimmunity for the benefit of patients. This position reports to the VP, Global Regulatory Affairs. The ideal candidate will contribute to our goals of navigating what’s next in synthetic biology, immunology and cell engineering while living our core values:

Bring Intellectual Rigor, Elevate Each Other, and Stay True To Why. Responsibilities:

Formulate, lead and drive global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for Cell and Gene Therapy projects/products. In close collaboration with Technical Operations and Program teams, lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements. In collaboration with Technical Operations and Program Teams, proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams. Lead, prepare and communicate CMC risk management assessments and lessons learned on major submissions. Provide regulatory review and impact/implementation assessment of proposed Change Control records and manage the associated Regulatory Notifications. Initiate and lead Health Authority interactions and negotiations related to CMC topics. Requirements:

Bachelor’s degree or Master's degree and 12+ years of regulatory CMC experience with direct experience in Cell and Gene Therapies. Global Cell and Gene Therapy Regulatory experience preferred. Trained in and/or experienced with Cell and Gene Therapy CMC requirements, supplemented with Regulatory professional certifications desirable. In depth knowledge/experience in regulatory submission and approval processes and ability to deal with complex CMC regulatory issues and requirements. Manage complex CMC regulatory challenges and requirements while leading/working in interdisciplinary teams. Well-developed planning, organizational, negotiation, problem solving and interpersonal skills. Excellent verbal, written and presentation skills and effectively communicate with all levels of management. Demonstrated expertise in critical thinking, influence, negotiation, problem solving, strategic thinking and leadership in a matrixed environment. Strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk. Ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives. Excel in a matrixed environment and build strong relationships by being transparent, reliable, and delivering on commitments. Must be a self-starter who works effectively in cross-functional teams. The base salary range for candidates residing in the California Bay Area for this position is $245,000 to $270,000 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. 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 on the basis of 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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