Research Scientist

ATR International; Santa Monica (CA); On-site; USD 39,000 - 65,000; Full time

Job summary

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.

Qualifications

• 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

Responsibilities

• 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

Skills

CAR-T biology

Biomarker analysis

Clinical pharmacology

Regulatory filings

Cross-functional collaboration

Data presentation

Education

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

Tools

NGS-based profiling

GxP bioanalytical assays

Job description

Pays up to $47.36 an hour depending on experience

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

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)

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