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 Director, Global Business Applications in its Information Technology organization to help advance its mission to free patients from the siege of autoimmune disease. 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 - Strategic Planning: Collaborating with business leaders to develop IT strategies that support and enable the achievement of business objectives.
- Technology Advisory: Providing expert advice and guidance on technology trends, emerging technologies, and best practices relevant to the business.
- Understanding Business Needs: Developing a deep understanding of the business functions, processes, goals, and challenges to identify opportunities where IT solutions can add value.
- Project Management: Overseeing the execution of IT projects from inception to completion, ensuring they are delivered on time, within budget, and meet quality standards.
- Budget Management: Collaborating with finance and business leaders to develop and manage IT budgets, ensuring resources are allocated effectively to support business priorities.
- Change Management: Manage changes to the global business applications landscape, ensuring proper documentation, validation, and compliance with regulatory requirements.
- Security and Compliance: Implement and maintain security measures to safeguard sensitive data within business applications, ensuring compliance with regulatory standards such as GDPR, HIPAA, and SOX.
- Cross-functional Collaboration: Collaborate with various departments (e.g., Quality Assurance, Regulatory Affairs, Manufacturing) to understand business needs and translate them into system requirements.
- Business Process Optimization: Collaborate with business stakeholders to understand their requirements and identify opportunities for process improvement through technology solutions. Analyze business processes and recommend enhancements or automation to streamline operations and increase efficiency.
- Vendor Management: Collaborate with external vendors and service providers to evaluate, select, and manage solutions and services related to global business applications.
- Documentation: Maintain accurate and up-to-date documentation for global business applications, including standard operating procedures (SOPs), work instructions, and compliance documentation.
- Audit Support: Support internal and external audits by providing documentation, conducting system walkthroughs, and addressing audit findings related to global business applications.
Requirements - Education: Bachelor's degree in Information Technology, Computer Science, or related field.
- Experience: 10+ years of experience in IT roles with a focus on global business applications support, administration, and/or implementation. Demonstrated experience working in a GxP-regulated environment.
- Regulatory Knowledge: Strong understanding of regulatory requirements relevant to GxP environments, including FDA regulations, EU Annex 11, and 21 CFR Part 11 compliance.
- Technical Skills: Proficiency in enterprise-level business applications such as ERP systems (e.g., SAP, Oracle), CRM systems, Document Management Systems (e.g., SharePoint), and other relevant technologies. Knowledge of programming languages, database management, and cloud computing platforms is a plus.
- Communication: Excellent verbal and written communication skills, with the ability to effectively communicate technical information to non-technical stakeholders.
- Problem-Solving Skills: Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues and implement effective solutions.
- Teamwork: Ability to work collaboratively with cross-functional teams and external partners to achieve common goals.
- Attention to Detail: Meticulous attention to detail, particularly concerning documentation and regulatory compliance requirements.
- Adaptability: Flexibility to adapt to changing priorities and business needs in a dynamic environment.
- Ethical Conduct: Commitment to upholding ethical standards and maintaining confidentiality in handling sensitive information.
- Project Management: Experience in project management methodologies and tools, with the ability to effectively manage multiple projects concurrently. Project Management Professional (PMP) certificate is a plus.
- Continuous Learning: Willingness to stay updated on industry trends, regulatory changes, and emerging technologies relevant to global business applications.
$230,000 - $241,000 a year
The salary range for candidates residing in California for this position is $230,000 USD to $241,000 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 geographic location, 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