Associate Director, GCLP and Clinical Pharamcology - Santa Monica, United States - Gilead Sciences

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Associate Director, GCLP and Clinical Pharamcology page is loaded

Associate Director, GCLP and Clinical Pharamcology

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locations

United States - California - Santa Monica

time type

Full time

posted on

Posted 6 Days Ago

job requisition id

R

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site

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, $225, 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:

• 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 . Sign up to follow @KitePharma on Twitter at

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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

for assistance.
For more information about equal employment opportunity protections, please view the

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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.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site

to apply for this job.

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.

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