Research Scientist, Biomarker Sciences I*

Lancesoft; Santa Monica (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Lancesoft is seeking a Research Scientist in Translational Medicine to support biomarker and translational strategies for CAR-T programs in Multiple Myeloma. You will bridge Research and Clinical Development, guiding PK/PD analyses, biomarker work, and regulatory interactions to advance pivotal study filings.

Ideal candidates have advanced degrees with 3+ years in industry (or an equivalent combination) and a strong background in cancer immunotherapy, MM biology, and regulatory submissions;

Qualifications

• Advanced scientific degree with 3+ years in industry OR Master’s with 5+ years of experience OR Bachelor’s with 7+ years of experience.
• Strong background in cancer immunotherapy, immunology and/or oncology with experience focusing on Multiple Myeloma
• Experience with regulatory filings and understanding of clinical landscape and regulatory expectations

Responsibilities

• Directs PK/PD analysis to support clinical pharmacology for CAR-T trials in Multiple Myeloma.
• Serves as Biomarker lead on clinical study teams and oversees data delivery and regulatory documentation for pivotal filings.
• Collaborates with Clinical Operations, Regulatory, Data Management and Biostatistics to advance trial data handling and analyses.
• Supports preparation of data packages for publication or regulatory submissions and engages with external researchers and KOLs.

Skills

Cancer immunotherapy

Immunology

Oncology

Clinical pharmacology

Regulatory filings

Biomarker analysis

Pharmacokinetics

Pharmacodynamics

Data presentation

Cross-functional collaboration

Education

Advanced scientific degree (MD, PharmD, PhD)

Master's degree in biology/related field

Bachelor's degree in biology/related field

Tools

NGS-based profiling

Job description

Internal Title: Research Scientist, Multiple Myeloma - Translational Medicine Schedule: M-F 8: 00-17: 00

Job Description 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 Client 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)