Senior Scientist, Translational Medicine – Auto-immune Diseases
United States - California - Santa Monica, United States - California - Foster CityResearchRegularJob Description
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job Description
The Senior Scientist will design and execute biomarker and translational strategy for the clinical development of Kite’s chimeric antigen receptor (CAR-T) programs in auto-immune indications. As a member of the Translational Medicine team, you will be at the intersection of Research and Clinical Development, providing valuable insight into the function of CAR-T cells in patients, the investigation of mechanisms of response and toxicity and the development of potential prognostic and predictive tools. You will facilitate clinical trial execution, synthesize scientific data, communicate key findings cross-functionally and regulatory filing.
Job Responsibilities
- Directs and establishes pharmacokinetic and pharmacodynamic (PK/PD) analysis to support clinical pharmacology for CAR T clinical trials in Auto-immune indications
- Serves as Biomarker lead on clinical study teams to oversee delivery of pharmacology data and documentation required for early phase, as well as pivotal and registrational study filings
- Reviews and contributes to clinical protocol design and study activities
- Identify and establish agreements with contract research organizations (CRO) and support the transfer of novel methods
- Collaborates with Clinical development teams including Clinical Operations, Regulatory, Clinical Data Management and Biometrics/Stats to advance data acquisition and analyses of clinical trial data
- Guides the resolution of clinical pharmacology/translational queries from regulatory agencies, supports writing and reviewing responses to regulatory queries.
- Support the preparation of data packages for publication, presentation and/or submission to regulatory agencies
- Collaborates with Bioinformatics, Statistical and analytical teams for exploratory biomarker correlative studies around disease biology and CAR T functionality
- Contribute to external scientific discussions/research collaborations and publications and engagement with key opinion leaders in the field
Basic Qualifications
Doctorate and 2+ years of scientific experience
OR
Master’s and 6+ years of scientific experience
OR
Bachelor’s and 8+ years of scientific experience
Preferred Qualifications
- Familiarity and experience with clinical and biomarker operations
- Prior experience in Regulatory filings
- Strong background in auto-immune diseases, immunology and/or cancer immunotherapy
- In-depth understanding of clinical landscape, evolving therapy, competitive scenarios
- Thorough understanding of clinical, translational, and mechanistic data
- Understanding of early or late-stage drug and translational development process; including clinical trial experience in industry or academia
- Familiarity with bioanalytical assay development and validation in a GxP environment
- Experience working with engineered T cells, immunophenotyping, and NGS-based approaches to profile the function of immune cells
- Comfortable in a matrixed and fast-paced company environment and able to adapt to changing priorities
- Strong collaboration, excellent interpersonal and communication skills
- Proficient with data presentations to communicate to a diverse cross-functional audience
- Maintain a high degree of accuracy and attention to details
- Ph.D. degree in biology-related field (immunology, bioinformatics or a closely related field)
The work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together. Ready to create more tomorrows with us? Hit apply.
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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 to apply for this job.