Research Scientist, Biomarker Sciences I*

Regulatory filing experience and a demonstrated ability to facilitate clinical trial execution, synthesize scientific data, communicate key findings cross-functionally is required. 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.

Job Title: Research Scientist, Multiple Myeloma 
Duration: 12 Months
Location: Santa Monica, CA Hybrid 
Schedule: M-F 8:00-17:00

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 

Education Level
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 

Experience
Preferred Qualifications: 
Strong background in cancer immunotherapy, immunology and/or oncology with experience focusing on Multiple Myeloma 
Prior experience in Regulatory filings 
In-depth understanding of multiple myeloma, knowledge of clinical landscape, evolving therapy, competitive scenarios  
Strong understanding of clinical, translational, and mechanistic data 
Familiarity and experience with clinical and biomarker operations 
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 tumor and 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 detail 
Ph.D. degree in biology-related field (immunology, cancer biology, bioinformatics or a closely related field)