Job description
The Executive Director, Clinical Operations is a senior leadership role focused on advancing the company’s mission to develop innovative cell therapies for autoimmune diseases. This position involves leading the operational strategy and delivery of clinical programs, ensuring alignment with corporate goals. This position will be a member of the Clinical Operations Leadership Team and will be accountable for the effective operational delivery and oversight of clinical programs. This individual will act as a role model for Kyverna’s core values and will be responsible for leading and participating in initiatives for process, technology or other continuous improvement to achieve cost-reduction, time savings, efficiency, quality and/or other business objectives. This individual will also be responsible for functional leadership in clinical operations, including direct line management (hiring, training, staff assignments, coaching, mentoring, and performance management).
Title: Executive Director, Clinical Operations
Reporting to: SVP of Clinical and Development Operations
Location: Emeryville, CA (Hybrid – twice a week) or Remote
Responsibilities
- Responsible for effective oversight of designated personnel and programs, as well as driving department goals and initiatives to desired outcomes
- Drive clinical operations inspection readiness strategy in preparation for BIMO inspections and/or other regulatory inspections
- Provide strategic input to ensure GCP compliance for the operational execution of Kyverna’s clinical programs
- Lead Clinical Operations study in inspection readiness activities, and mock and real inspections
- Drive design, development, and partner with QA on implementation of SOPs, study document templates, change controls and training programs to support quality, GCP compliance and inspection readiness
- Partner with QA department to manage study specific training and ensure adherence to GCP compliance execution
- Participate in development of KPIs aligned with clinical operations study teams and leadership goals focused on performance drivers and key issues, risks and business drivers
- Leads 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 such as Master’s or PhD degree preferred.
- 15+ years of pharmaceutical/biotech/CRO clinical research operations experience in Phase I-IV studies.
- 12+ years of line management responsibility and knowledge of performance management best practices.
- Experience problem solving in challenging clinical studies and working knowledge of GCP/ICH, GDPR (General Data Protection Regulation), clinical trial design, regulatory, and clinical development processes.
- Experience in complex autoimmune disorders, rheumatology, neurology, complex rare diseases, or cell therapy is preferred.
- 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 approximately 20%
The salary range for this position based in No. California is from $275,000 to $310,000 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.
