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

Kite Pharma•Santa Monica, CA

12h

About The Position

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 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.

Requirements

PharmD, PhD, with 2+ years of relevant clinical or related life sciences experience.
MA/MS with 4+ years relevant clinical or related life sciences experience
BA/BS/RN with 6 + years relevant clinical or related life sciences experience.
Demonstrated experience with deviations, CAPA, or operational incident management in a regulated environment.
Experience with EAP delivery and regulatory submissions (IND/sIND) is highly preferred.
Experience managing the work of external vendors
ability to travel

Nice To Haves

Experience in cell therapy manufacturing/supply chain, apheresis, lot release, and chain-of-identity/chain-of-custody processes.
Familiarity with ICH guidelines, FDA/EMA expectations, and Medical Affairs compliance frameworks.
Experience with relevant systems: Veeva Vault/MedComms/Quality, TrackWise, Salesforce/CRM, Safety databases, data visualization tools (e.g., Power BI, Tableau).
Thorough knowledge of Food and Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, international council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP)governing the conduct of clinical studies.
Experience with out of specification process and release criteria protocols
Operational Excellence
Risk Management
Cross-Functional Leadership
Analytical Thinking
Compliance Mindset
Scientific & Clinical Acumen

Responsibilities

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.
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).
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.
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.
Ensure all OOS activities adhere to regulations and Kite SOPs.
Support audits/inspections by preparing sIND/EAP documentation, training records, and metrics.
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.
Define and track KPIs, trends, and signal detection for OOS programs.
Present insights to leadership with recommendations.
Implement continuous improvement initiatives (process optimization, tech enablement, training efficacy, feedback loops).

Benefits

This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume