Research Scientist, Biomarker Sciences

ACL Digital; Santa Monica (CA); Hybrid; USD 130,000 - 180,000; Full time

Job summary

ACL Digital is seeking a Research Scientist for Translational Medicine focused on Multiple Myeloma CAR-T programs in Santa Monica. You will integrate bioanalytics with clinical development, directing PK/PD analyses and leading biomarker strategies across pivotal trials.

Advanced degrees with 3+ years in industry, or equivalent master/bachelor level experience, are required. Hybrid work setup with cross-functional collaboration and regulatory engagement are central to this role.

Qualifications

• Advanced degree and 3+ years in industry or
• Master's degree with 5+ years of experience or
• Bachelor's with 7+ years of experience in relevant field.

Responsibilities

• Directs PK/PD analyses to support CAR-T trials in Multiple Myeloma.
• Acts as biomarker lead to oversee pharmacology data delivery for pivotal studies.
• Reviews and contributes to clinical protocol design and study activities.
• Identifies CROs and supports transfer of novel methods.
• Collaborates with Clinical Operations, Regulatory, Data Management and Biometrics to advance data acquisition.
• Leads resolution of regulatory queries and supports responses.
• Prepares data packages for publications and regulatory submissions.
• Collaborates with Translational Medicine, Bioinformatics and Stats for exploratory studies.
• Engages with external scientists and key opinion leaders.

Skills

PK/PD analysis

Regulatory communications

Clinical trial execution

Education

MD/PhD/PharmD

Master's degree

Bachelor's degree

Job description

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