Research Scientist, Multiple Myeloma - Translational Medicine

Planet Pharma; Santa Monica (CA); On-site; USD 55,000 - 65,000; Full time

Job summary

Planet Pharma is seeking a Research Scientist to support biomarker and translational strategy for CAR-T programs in Multiple Myeloma. You will bridge Research and Clinical Development, informing on CAR-T cell function in patients and potential prognostic tools.

Responsibilities include leading PK/PD analyses, serving as Biomarker lead on study teams, and contributing to regulatory filings. Advanced degree with 3+ years in industry is required; strong collaboration and communication skills are

Qualifications

• Requires advanced scientific degree with industry experience in translational science.
• Regulatory filings experience is required.
• Strong understanding of cancer immunotherapy and multiple myeloma.
• Experience with clinical pharmacology and PK/PD analyses.

Responsibilities

• Directs PK/PD analyses to support clinical pharmacology for CAR T trials.
• Biomarker lead on clinical study teams; oversees data delivery for filings.
• Contributes to protocol design and study activities.
• Identifies CROs and supports transfer of novel methods.
• Collaborates with Clinical Operations, Regulatory, Data Management, Biometrics to advance data analyses.
• Leads responses to regulatory queries and prepares data packages for publication.
• Collaborates with Translational Medicine, Bioinformatics and Stats for exploratory biomarker studies.
• Engages with external scientists and key opinion leaders.

Skills

CAR-T biology

biomarker analysis

Regulatory filings

clinical pharmacology

data presentation

cross-functional collaboration

NGS-based profiling

communication

Education

PhD/MD/PharmD with 3+ yrs experience

Master's degree with 5+ yrs

Bachelor's degree with 7+ yrs

Tools

GxP analytics

NGS data analysis tools

bioinformatics pipelines

Job description

The Research Scientist will support biomarker and translational strategy for the clinical development of Kites 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

Education Level

• Advanced scientific degree (i.e. MD, PharmD, PhD) and 3+ years in industry
• Master's Degree and 5+ years of scientific experience
• 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)

Pay ranges between 40-47/hr based on experience