Research Scientist

Integrated Resources, Inc ( IRI ); San Mateo (CA); Hybrid; USD 54,000 - 77,000; Full time

Job summary

Integrated Resources, Inc (IRI) is seeking a Research Scientist - Biomarker Sciences for its hybrid role in Foster City, CA. You will support CAR-T biomarker strategy and translational science to inform clinical development, with direct involvement in PK/PD analyses and regulatory interactions.

The role requires a PhD or advanced degree with industry experience, strong immunology/cancer biology background, and effective cross-functional collaboration within Translational Medicine teams.

Qualifications

• PhD or higher with 3+ years in industry.
• Experience with Regulatory filings for clinical programs.
• Strong understanding of CAR-T biology and Multiple Myeloma.
• Experience with PK/PD and translational data.

Responsibilities

• Directs PK/PD analysis to support CAR-T clinical pharmacology.
• Leads biomarker work on clinical studies and data packages.
• Contributes to protocol design and study activities.
• Collaborates with cross-functional teams to advance trial data.
• Interacts with Regulatory agencies and responds to regulatory queries.
• Supports publications and external collaborations.

Skills

PK/PD analysis

Biomarker

Cancer immunotherapy

Clinical pharmacology

Regulatory filings

Team collaboration

NGS-based profiling

Translational medicine

Data interpretation

Scientific communication

Education

PhD in biology-related field

Advanced degree (MD/PhD/PharmD)

Master’s degree in life sciences

Bachelor’s degree in life sciences

Job description

Title: Research Scientist - Biomarker Sciences - I*

Location: Foster city, CA – Hybrid role

Schedule: M-F 8:00-17:00

Pay rate: $47.35/hour on W2.

Job Description

The Research Scientist will support biomarker and translational strategy for the clinical development of Client’s 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

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)
• 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