Associate Director, Clinical Pharmacology

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 DescriptionAs 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#IND123The 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 .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.For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/ofccp/pdf/pay-transpformattedESQA508c.pdf)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 (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 UsEveryone 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.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all Canada, Australia, Singapore, and Hong Kong employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. The health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority.The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request an accommodation.