Clinical Biomarker Lead - CAR-T/ Multiple Myeloma

Research Scientist – Multiple Myeloma / Translational Medicine
Location: – Hybrid
Schedule: Monday–Friday, 8:00 AM–5:00 PM
Duration: 1-Year Contract
Job Summary
We are seeking a Research Scientist to support biomarker and translational strategies for the clinical development of CAR-T programs in Multiple Myeloma.
This position sits within the Translational Medicine team and works closely with Research and Clinical Development to understand CAR-T cell function in patients and support the development of potential prognostic tools. The ideal candidate will have experience with translational medicine, biomarkers, clinical trials, oncology/immunology, and regulatory submissions.
Key Responsibilities
Direct and establish PK/PD analyses supporting clinical pharmacology for CAR-T clinical trials in Multiple Myeloma.
Serve as a Biomarker Lead on clinical study teams and oversee pharmacology data and documentation for pivotal and registrational studies.
Review and contribute to clinical protocols and study activities.
Identify and establish relationships with CROs and support the transfer of novel methods.
Collaborate with Clinical Operations, Regulatory, Clinical Data Management, Biometrics/Statistics, and Clinical Development teams.
Lead resolution of clinical pharmacology and translational questions from regulatory agencies and support regulatory responses.
Prepare data packages for publications, presentations, and regulatory submissions.
Partner with Translational Medicine, Bioinformatics, and Statistical teams on exploratory biomarker studies and analysis of tumor biology and CAR-T functionality.
Contribute to external scientific collaborations, publications, and KOL engagement.
Required Education & Experience
MD, PharmD, or PhD + 3+ years of industry experience, OR
Master’s degree + 5+ years of scientific experience, OR
Bachelor’s degree + 7+ years of scientific experience.
Preferred Qualifications
Experience in cancer immunotherapy, immunology, and/or oncology, preferably Multiple Myeloma.
Experience with regulatory filings and submissions.
Strong understanding of the Multiple Myeloma clinical landscape and treatment approaches.
Strong knowledge of clinical, translational, and mechanistic data.
Experience with clinical and biomarker operations.
Understanding of early- and/or late-stage drug development and clinical trials.
Experience with bioanalytical assay development and validation in a GxP environment.
Experience working with engineered T cells, immunophenotyping, and NGS-based approaches to assess tumor and immune cell function.
Strong cross-functional communication and collaboration skills.
Ability to present complex scientific data to diverse audiences.
Strong attention to detail and ability to work effectively in a fast-paced, matrixed environment.
PhD in Immunology, Cancer Biology, Bioinformatics, Biology, or a related field is preferred.
Interested candidates can apply with an updated resume.
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