Scientist - 26-00993

LeadStack Inc.; Santa Monica (CA); Hybrid; USD 48,000 - 65,000; Full time

Job summary

LeadStack Inc. is seeking a Research Scientist for Translational Medicine in Santa Monica, CA, focusing on Multiple Myeloma CAR-T programs.

This contract role supports biomarker strategies and translational science bridging the gap between lab findings and clinical development. The candidate will lead PK/PD analyses, manage regulatory filings, and collaborate across Clinical Development, Regulatory, and Biometrics teams to advance trial data and publications.

Qualifications

• Advanced degree required with 3+ years in industry.
• Experience with regulatory filings.
• Experience with CAR-T programs and translational medicine.

Responsibilities

• Directs PK/PD analyses to support clinical pharmacology for CAR-T trials in MM.
• Serve as Biomarker lead on clinical study teams and oversee pharmacology data delivery for filings
• Review and contribute to clinical protocol design and study activities
• Identify and establish CRO partnerships and support transfer of novel methods
• Collaborate with Clinical Operations, Regulatory, Data Management and Biostatistics to advance trial data analyses
• Lead resolution of regulatory queries and support responses
• Prepare data packages for publication with medical writers and submissions
• Collaborate with Translational Medicine and Bioinformatics teams on exploratory biomarker studies
• Engage in external scientific discussions and collaborations with key opinion leaders
• Advanced degree and 3+ years in industry or a Master’s with 5+ years or Bachelor’s with 7+ years experience

Skills

PK/PD analysis

Regulatory filings

Biomarker

CAR-T

Clinical development

Data analysis

Communication skills

Team collaboration

Translational medicine

Education

PhD in biology-related field

Master's degree in related field

Bachelor's degree

Job description

Job Title

Research Scientist, Multiple Myeloma - Translational Medicine

Location

Santa Monica, CA – 90404 - Hybrid

Duration

12 months Contract

Payrate

$35/hr - $47/hr on W2

Job Description

• 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

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)