Arcellx · 1 day ago
Senior Scientist, Translational Biomarkers
Rockville, MD
Full-time
Onsite
Mid, Senior Level
$125K/yr - $145K/yr
5+ years expArcellx is a public, clinical-stage biotechnology company focused on developing innovative immunotherapies for cancer and other incurable diseases. The Senior Scientist in Translational Biomarkers will design and execute clinical biomarker assays, ensure compliance with regulatory standards, and collaborate with various teams to advance clinical trial data acquisition and analyses.
BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical
Responsibilities
Design, develop, validate and execute robust fit for purpose clinical biomarker assays to support secondary and exploratory endpoints in clinical safety and efficacy studies
Responsible for ensuring biomarker methods are compliant with ICH Q2 guidelines and meet regulatory standards
Manage the transfer, bridging and validation of biomarker assays at CROs
Contribute to biomarker plans and strategies for addressing key translational questions such as understanding the mechanism of action (MOA), pharmacokinetics and pharmacodynamics of drug candidates
Collaborate with external partners, Clinical Operations, Clinical Data Management and Biometrics to advance data acquisition and analyses of clinical trial data
Analyze, interpret, prepare and present data summaries, communicate next steps and provide recommendations to internal teams and stakeholders
Contribute to regulatory document preparation such as clinical protocol, regulatory responses, and submissions
Identify, evaluate and integrate new technologies to support evolving translational biomarker strategies
Write and review SOPs, technical protocols and reports
May supervise associate scientists and support their professional development
Qualification
Required
PhD in immunology, immuno-oncology, molecular and cellular biology or related field
5+ years of biomarker experience in the pharmaceutical industry
Strong understanding of various technology platforms and datasets used to support clinical biomarker assays used to support early to late phase clinical trials
Strong technical expertise in developing, validating and implementation of clinical biomarker, immunological, molecular and gene expression assays including multi-parameter flow cytometry (>12 colors), immunohistochemistry (IHC), droplet digital PCR (ddPCR), RNA isolation/sequencing, gene expression with platform such as Nanostring
Subject Matter Expert (SME) on validation of analytical methods per ICH Q2 guidelines
Strong data analysis capabilities of high dimensional data using Flowjo or data packages such as Cytobank
Experience managing CROs and ensuring high-quality, timely delivery of biomarker data, with a demonstrated understanding of ICH/GCP and regulatory requirements
Strong problem-solving skills and ability to independently oversee scientific projects, rigorously analyze and interpret scientific data while maintaining attention to detail
Effective communication skills, with the ability to present complex data to diverse audiences
Experience working in a GCLP regulated environment and extensive knowledge of GLP/GCP complaint studies
Preferred
Knowledge of R and/or Python
Benefits
100% coverage for medical, dental and vision for team members and dependents
Unlimited vacation
A 3-day weekend every month
Fully-paid parental leave for up to 6 months
Tuition reimbursement
401k employer contribution
Relocation assistance for roles if required
Company
Arcellx
Arcellx is a clinical-stage biotechnology company that provides patients with immune cell therapies.
51-200 employees
H1B Sponsorship
Arcellx has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (4)
2022 (2)
Funding
Current Stage
Public CompanyTotal Funding
$622MKey Investors
Kite Pharma
2023-11-15Post Ipo Equity· $200M
2022-12-09Post Ipo Equity· $100M
2022-06-15Post Ipo Equity· $112M
Leadership Team
Michelle Gilson
Chief Financial Officer
Brad Gliner
Vice President, Clinical Research and Regulatory Affairs
Recent News
2025-12-11
2025-12-08
Company data provided by crunchbase