Associate Director, GCLP and Clinical Pharamcology

Descripción del trabajo

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!

#LI-ML1

#IND123