CAR-T Translational Scientist: Biomarkers & PK/PD Lead

ATR International; Santa Monica (CA); In loco; USD 39.000 - 65.000; Tempo pieno

Descrizione del lavoro

ATR International in Santa Monica, CA is seeking a Research Scientist to support biomarker and translational strategy for CAR-T programs in Multiple Myeloma. You will intersect Research and Clinical Development, providing insight into CAR-T cell function, biomarker development, and regulatory filings.

The role requires experience with regulatory submissions, cross-functional teamwork, and data synthesis for clinical trial execution.

Competenze

• Strong background in cancer immunotherapy and/or oncology focusing on Multiple Myeloma
• Experience with regulatory filings for clinical programs
• Understanding of clinical translational data and mechanistic links to biomarkers
• Familiarity with bioanalytical assay development and validation in a GxP environment
• Experience with engineered T cells and immunophenotyping or related profiling methods
• Ability to communicate complex data to cross-functional teams

Mansioni

• Directs PK/PD analysis to support clinical pharmacology for CAR-T trials in Multiple Myeloma
• Biomarker lead on clinical study teams overseeing pharmacology data for pivotal studies
• Contributes to protocol design and study activities for translational programs
• Establishes CRO agreements and supports transfer of novel methods
• Collaborates with Clinical Development, Regulatory, Data Management and Biostatistics to advance data collection and analyses
• Leads responses to regulatory queries and prepares data packages for publications or regulatory submissions
• Engages with Translational Medicine, Bioinformatics and Statistical teams for exploratory biomarker studies
• Contributes to external scientific discussions and publications
• Maintains high accuracy and attention to detail

Conoscenze

CAR-T biology

Biomarker analysis

Clinical pharmacology

Regulatory filings

Cross-functional collaboration

Data presentation

Formazione

Ph.D. in immunology/biology

Advanced degree (MD/PhD/PharmD) + 3+ years industry

Master's degree + 5+ years experience

Bachelor's degree + 7+ years experience

Strumenti

NGS-based profiling

GxP bioanalytical assays

Descrizione del lavoro

ATR International in Santa Monica, CA is seeking a Research Scientist to support biomarker and translational strategy for CAR-T programs in Multiple Myeloma. You will intersect Research and Clinical Development, providing insight into CAR-T cell function, biomarker development, and regulatory filings.

The role requires experience with regulatory submissions, cross-functional teamwork, and data synthesis for clinical trial execution.