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Associate Director, GCLP and Clinical Pharamcology

United States - California - Santa MonicaResearchRegular

Job Description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.


 

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.


 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.

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. Gilead 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.


For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic 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 laws. In 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 ApplicantAccommodations@gilead.com for assistance.

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