Sr. Director, Clinical Operations

Responsibilities

• Member of the Clinical Operations Leadership Team, responsible for effective oversight of designated personnel and programs, as well as driving department goals and initiatives to desired outcomes. 
• Support the design and delivery of a product or indication level program within the Clinical Operations team.
• Provide a strategic view on operational planning, direction and delivery aligned to corporate goals.
• Provide strong input to the Product Core Team, where required, in aspects of ideation, planning, delivery and issue escalation throughout, for clinical programs. 
• Drive meaningful internal and external relationships (CRO, Academic Partners, Advocacy Groups) for the benefit of the programs.
• Be a cross functional guide in the planning and delivery of clinical programs to ensure that the Kyverna development work is cohesive and efficient.
• Build and develop high performing clinical operations teams. Responsible for performance tracking and assessment within the team, consistent with Kyverna best practices. 
• Ensure integrated program planning for enrollment, timelines, and costs in collaboration with cross functional team is occurring and deliver plans and updates ready for 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.
• Build demand model for CAR-T manufacturing with Technical Operations relevant to specific programs and quickly identify and communicate all changes to planning model Lead projects outside of clinical trial delivery to build and improve the capability of the R&D organization in response to evolving business needs.
• Excels in actions around problem identification, cross functional collaboration, and implementation of planned resolution.
• 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 required. 
• Advanced degree (Master’s or PhD) preferred.
• 12+ years of pharmaceutical/biotech/CRO clinical research operations experience in Phase I-IV studies. 
• Problem solving in challenging clinical studies. Working knowledge of GCP/ICH, GDPR (General Data Protection Regulation), clinical trial design, regulatory, and clinical development processes.
• 8+ years of line management responsibility and knowledge of performance management best practices.
• Experience in complex autoimmune disorders, rheumatology, neurology, complex rare diseases, or cell therapy preferred. 
• Self-starter, with a 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%.