Research Scientist, Biomarker Sciences

Title: Research Scientist, Multiple Myeloma - Translational Medicine Location: Santa Monica, CA (Hybrid) Duration: 12 months Summary The Research Scientist will support biomarker and translational strategy for the clinical development of chimeric antigen receptor (CAR-T) programs in Multiple Myeloma. 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 and the development of potential prognostic tools. Regulatory filing experience and a demonstrated ability to facilitate clinical trial execution, synthesize scientific data, communicate key findings cross-functionally is required. Key Responsibilities Directs and establishes pharmacokinetic and pharmacodynamic (PK/PD) analysis to support clinical pharmacology for CAR T clinical trials in Multiple Myeloma Serves as Biomarker lead on clinical study teams to oversee delivery of pharmacology data and documentation required for 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 Leads 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 with medical writers, presentation and/or submission to regulatory agencies Collaborates with Translational Medicine, Bioinformatics and Statistical teams for exploratory biomarker correlative studies and deeper analysis of tumor biology and CAR T functionality Contribute to external scientific discussions/research collaborations and publications and engagement with key opinion leaders in the field Advanced scientific degree (i.e. MD, PharmD, PhD) and 3+ years in industry OR Master's Degree and 5+ years of scientific experience OR Bachelor's Degree and 7+ years of scientific experience #J-18808-Ljbffr ACL Digital