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Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.

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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 Kites 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 Kites cell therapy products including developing ways of working both internally and externally to deliver both single patient INDs 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).

Qualifications

Required

• 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
• When needed ability to travel

Preferred

• 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

Core Competencies

• Operational Excellence
• Risk Management
• Cross-Functional Leadership
• Analytical Thinking
• Compliance Mindset
• Scientific & Clinical Acumen

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.

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Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

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Please apply via the Internal Career Opportunities portal in Workday.