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Principal Scientist, Translational Medicine

Santa Monica, CA, USA | Leading Pharmaceutical / Biotech Company

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
    Full-Time
  • Functions:
    Biotech/R&D/Science
  • Experience:
    5-7 years
Job Description:
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Job Description

We are seeking a self-motivated and ambitious person with a strong work ethic to join us as a Principal Scientist within the Department of Translational Medicine (TM). In this position, you will work with the TM team to directly support clinical development of Kite’s chimeric antigen receptor (CAR-T) oncology programs. The successful person will aid in the design and execution of translational strategy pivotal to Kite’s CAR-T pipeline and aid in reverse translational initiatives (bedside to bench). A demonstrated ability to support clinical trial execution, synthesize scientific data and communicate key findings cross-functionally is required. You will also be asked to perform other duties as required to support Kite’s pipeline development.


Key Responsibilities:


Support design of CAR T clinical trial pharmacology and discovery biomarker strategy

Serve as TM lead and oversee delivery of key pharmacology data deliverables required for registrational studies (pharmacodynamic, pharmacokinetic, safety related and detailed product characterization information)

Work with Clinical Data Management and Biometrics to qualify data acquisition and aid in interpretation of analyses of clinical trial data

Support the preparation of data packages for publication, presentation and/or submission to regulatory agencies

Contribute to company-wide and external scientific discussions and engagement with key opinion leaders in the field

Identify and establish agreements with contract research organizations (CRO) and support the transfer of novel methods

Supply to internal technology evaluation, development, qualification, and execution of innovative assays for clinical biospecimen monitoring

Write, review, and edit technical documents including SOPs, development/qualification of protocols and drafting of study reports

Support globally regulatory requests including Investigational New Drug (IND), Biologics License Application (BLA) and other key global regulatory filing activities

Other duties as applicable

Requirements:


PhD degree with demonstrated experience in cell therapy, immunology, cancer biology or a closely-related field and 5+ years of industry or meaningful experience

Familiarity in the areas of cell therapy, immunology, immuno-oncology and cancer biology

Understanding of basic CAR-T cell pharmacokinetic and pharmacodynamic studies

Previous clinical trial experience in the setting of translational biology desirable

Experience with relevant diagnostic technologies with an emphasis on flow cytometry, multiplexed immunoassay, and PCR methods

Knowledge of scientific applications such as GraphPad Prism, FlowJo, FACSDiva and Spotfire are highly desirable

Experience with clinical biospecimen testing, assay development and qualification

Knowledge of laboratory information management system (LIMS) and electronic lab notebook record keeping (ELN)

Strong personal leadership, interpersonal and record-keeping skills

Excellent social, verbal and written communication skills are essential in this reciprocal work environment

Comfortable in a dynamic environment and able to adapt to changing priorities

Self-motivated and ambitious person with a strong work ethic


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