For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

At Kite, we empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

Job Description

As the largest, dedicated in-house cell therapy manufacturing network in the world, Kite has relentlessly focused on developing our industry-leading manufacturing capabilities to bring the hope of survival to more patients living with certain difficult-to-treat cancers.

The Clinical Pharmacology Associate Director will be the GCLP scientific expert and point of contact for the oversight of clinical biomarker assessments, supporting the development of Kite’s chimeric antigen receptor (CAR-T) programs. As a member of the Translational Medicine team, you will be at the intersection of Research and Clinical Development, facilitating assay development, qualification or validation in a regulated environment. The candidate will have up to date knowledge of best practices in clinical blood biomarker and flow cytometric analysis. A demonstrated ability in executing such clinical trial biomarker assessments following GCLP guidelines is required.

Key Responsibilities:

• Oversees in-house GCLP infrastructure, systems and procedures to ensure adequate and phase-appropriate laboratory practices for analytical methods and testing in cell therapy clinical studies

• Reviews and approves analytical methods and systems validation including but not limited to assay validation and analytical instrument procedural documents and change control reviews.

• Provides overall guidance on requirements for GCLP documentation of validation activities

• Partners with Clinical Pharmacology PK/PD/ Flow cytometric labs to oversee assay development and review qualification and validation plans, maintenance of SOPs, and identification of critical reagents

• Assures analytical instruments are maintained in a compliant state.

• Identifies and resolves quality issues and employs mitigation strategies for future work

• Supports development and implementation of LIMS and integration of data with central data management

• Assists in writing regulatory submissions and in responding to regulatory queries and audits as needed

• Supports regulatory agency inspections and vendor audits as needed.

• Participates in compliance projects and initiatives cross functionally as the Translational Medicine Clinical Pharmacology GCLP representative.

Basic Qualifications:

• Doctorate and 2+ years of relevant experience OR

• Master’s and 8+ years of relevant experience OR

• Bachelor’s and 10+ years of relevant experience OR

• Associate and 12+ years of relevant experience OR

• High School Diploma/GED and 14+ years of relevant experience

Preferred Qualifications:

• Familiarity with clinical biomarker assessments in cell therapy and or a related I/O field within a regulated environment

• Experience with both early and late-phase clinical trial bioanalytical analysis

• Proficiency with diverse bioanalytical assays, including but not limited to ddPCR, qPCR, MSD, ELISA and flow cytometry

• Familiarity with CSV validation and CFR Part 11 compliance

• Prior exposure to Quality Assurance practices

• Knowledge of scientific applications such as GraphPad Prism, FlowJo, FACSDiva and Spotfire are desirable

• Ability to manage multiple projects in a fast-paced environment and able to adapt to changing priorities

• Excellent organizational skills and attention to detail

Does this sound like you? If so, apply today!

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The salary range for this position is: $173,910.00 - $225,060.00. 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.

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 system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Change The World With Us

Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.

We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.

While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.