Manager, Out-of-Specification (OOS) & Expanded Access Program – Medical Affairs (Cell Therapy)

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About the role

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description 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

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