Job DescriptionThe 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 & Analytics
- 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).
Basic Qualifications: - MA/MS with 4+ years relevant clinical or related life sciences experience OR
- BA/BS/RN with 6 + years relevant clinical or related life sciences experience.
Preferred Qualifications: - 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.
- Demonstrated experience with deviations, CAPA, or operational incident management in a regulated environment.
- Experience with EAP delivery and regulatory submissions (IND/sIND) is highly.
- Experience managing the work of external vendors
- 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
Core Competencies - Cross-Functional Leadership
- Scientific & Clinical Acumen
People Leader Accountabilities:- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $133,195.00 - $172,370.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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.
