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Job Description

Position Summary

The Manager, OOS & Expanded Access Program will lead the end-to-end Out-of-Specification (OOS) program for Medical Affairs across Kite’s cell therapy portfolio, ensuring compliant, timely, and clinically sound management of OOS events. This role is also responsible for the delivery and operational excellence of the Expanded Access Program (EAP) for new therapy launches, including the development and implementation of a Screening IND (sIND) portal. The position requires strong clinical operations expertise, cross-functional leadership, and deep understanding of regulatory, safety, and Medical Affairs frameworks.

Key Responsibilities

OOS Program Leadership

• Establish and operationalize an enterprise OOS event management framework for Kite’s cell therapy products, including developing ways of working both internally and externally to deliver both single patient IND’s and coordinate the Expanded Access Program.
• Develop and maintain standard operating procedures (SOPs), work instructions, ensure regulatory and safety regulations are followed, and documentation is maintained. Serve as the single point of contact across Kite for any questions regarding sIND or the EAP programs for all cell therapy programs. Work cross functionally with MRB (Materials Review Board), Medical Affairs, Clinical Operations, Technical Operations, Safety and Regulatory functions to ensure a compliant program.
• Lead OOS risk assessments and determine Medical Affairs implications (patient impact, HCP communications, field actions, medical information updates) as needed on an ongoing basis.

Expanded Access Program (EAP) Delivery

• Design, implement, and manage the EAP for new cell therapy launches, ensuring regulatory and safety compliance across all processes.
• Serve as the primary Medical Affairs liaison for EAP operations, collaborating with Regulatory, Quality, Clinical Operations, Clinical Development Supply Chain, and Field Medical teams.
• Coordinate and liaise with Kite Konnect operationalization team and the Kite Konnect Case Manager team to develop and implement integration for the sIND and EAP portal within Kite Konnect (future goal).

sIND Portal Development

• Lead the development and implementation of a sIND portal to streamline intake, triage, and tracking of expanded access and OOS cases.
• Manage the relationship with contracted Vendor in conjunction with Gilead MAP program lead for contracting to ensure contracting is completed and adjusted as needed ongoing.
• Partner with IT, Regulatory, Quality, and Clinical Operations to ensure the portal meets compliance, data integrity, and user requirements.

Cross-Functional Collaboration

• Coordinate activities with Quality (QC/QA), Manufacturing, Regulatory Affairs, Pharmacovigilance/Safety, Supply Chain, Clinical Development, Compliance, Legal, and Medical Affairs or OOS and EAP events.
• Serve as the Medical Affairs point of contact for OOS program (sIND and EAP) – developing and ensuring strong collaboration with MA to provide seamless access to sites to the OOS program.
• Partner with Field Medical (MSLs) and Medical Information to align messaging, FAQs, response letters, and escalation pathways.

Compliance & Governance

• Ensure all OOS activities adhere to regulations and Kite SOPs.
• Support audits/inspections by preparing sIND/EAP documentation, training records, and metrics.

Training & Communication

• Develop and deliver training for cross functional colleagues to the new OOS program, including ways of working, and responsibilities for each department. (This will include clinical operations, Medical Affairs, Regulatory, Safety, Tech Ops and Kite Konnect but may include others)
• Create an OOS program playbook for reference teams to reference.

Continuous Improvement &