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Director, Clinical Quality
4 months ago
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 highly motivated Director of Clinical Quality to establish and lead our GCP/GLP/PV quality efforts and advance our mission to free patients from the siege of autoimmune disease. As a Leader in the Quality Function, this individual will build and lead a Quality Unit focusing on clinical quality oversight for our clinical development programs both in the US and internationally, including oversight of contract labs supporting the clinical studies and non-clinical studies, ensuring our adherence to regulatory requirements, and maintaining the highest standards of quality in our clinical operations.
This position will collaborate with internal clinical and nonclinical functions and external parties including consultants, contract auditors, CROs and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for all programs. Additionally, this position will independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners, and internal systems in compliance with GCP, GLP, and Company policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations. The Director will support a culture of sustainable compliance; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready.
The ideal candidate will have deep experience in Clinical Quality oversight of biopharmaceutical products with additional experience in managing trials involving autologous or allogeneic genetically modified cell therapies. They will contribute to our goals while living our core values: Bring Intellectual Rigor, Elevate Each Other, and Stay True to Why.
If you are passionate about transforming the lives of patients and making significant contributions to the field of cell therapy, we invite you to join us; and together we can drive forward innovative treatments and improve the standard of care to tame autoimmune diseases
Responsibilities:
* Utilize advanced, international GCP expertise and management experience to develop, execute, and optimize cost effective, risk-based, quality assurance and compliance programs.
* Develop and implement a strategic vision for GCP/GLP Quality Assurance to align with business objectives. Design and build the GCP/GLP Quality Unit.
* Drive the execution of a scalable, cost effective, and risk-based quality assurance and compliance infrastructure related to clinical trial oversight, site compliance and safety monitoring and reporting.
* Support international clinical trials through quality oversight, program/study team consultation, and risk assessment.
* Participate in Site activation, initiation and qualification activities as required.
* Develop and maintain the GCP audit strategy and audit plan in collaboration with program/study teams and in line with program timing and objectives. Perform vendor and clinical site evaluations, as required.
* Collaborate with cross-functional teams to address findings and implement corrective and preventive actions. Maintain and update the CAPA process to ensure the audit reports and corrective actions are developed and completed within timelines mandated in internal procedures.
* Act as the primary point of contact for regulatory agencies and lead GCP health authority audits and inspections. Implement Inspection Readiness program and provide leadership for GCP inspection readiness training and preparation for MOCK BIMO interview/audits and provide GCP compliance technical support during inspections of investigator sites. Participate in regulatory agency inspections.
* Represent QA in Program Teams, sub-teams and study teams where relevant and provide input, guidance, and oversight to ensure clinical trials are conducted in compliance with clinical protocols, GCP and other regulatory requirements.
* Plan/strategize inspection readiness activities to support program/study team.
* Establish and manage a robust quality management system to support clinical operations including developing and implementing policies, procedures, and processes that align with industry best practices and regulatory requirements. Continuously evaluate and enhance the quality systems to drive efficiency and compliance. · Lead investigations into significant quality issues related to GCP elements, product handling, administration, or safety. Facilitate identification of root cause, and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
* Oversee the development, implementation, and maintenance of quality systems, processes, and procedures related to GCP/GLP and clinical trial oversight.
* Recruit, train, and mentor a high-performing team of quality assurance professionals.
* Foster close collaboration with clinical development, regulatory affairs, clinical operations, patient operations, medical affairs, and other departments to ensure alignment and coordination in quality compliance activities. Provide guidance and support to these teams on quality-related matters.
* Maintain expert up-to-date knowledge on GCP legislation and relevant parts of GxP guidelines, requirements and practices and ensure that the information is integrated into the Quality and Operating processes within Kyverna and the organizations supporting clinical development.
Requirements:
* Advanced degree in life sciences, pharmacy, or a related field.
* Minimum of 10 years of experience in GCP/GLP compliance and monitoring within the biotechnology or pharmaceutical industry, with a focus on autologous and allogeneic cell therapy treatments preferred.
* Strong knowledge of applicable regulatory requirements, including FDA and EMA regulations and ICH guidelines, with an emphasis on requirements associated with the study of cells and tissues, particularly genetically modified cells as therapies.
* Proven track record in developing and implementing quality systems and processes in a clinical setting.
* Successful management of audits and inspections by regulatory agencies.
* Excellent verbal, written and presentation skills to effectively communicate with all levels of management.
* Demonstrated expertise in critical thinking, influence, negotiation, problem solving, strategic thinking and leadership in a matrix environment.
* Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk.
* Excellent leadership skills with the ability to influence and collaborate effectively across cross-functional teams.
* Strong analytical and problem-solving skills, with a focus on risk management and continuous improvement.
* Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
* Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
* Self-starter, works effectively in teams.
The salary range for candidates residing in California for this position is $195,000 USD to $230,000 USD 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, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company's stock option plan.
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 identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
