Title: Research Scientist, Multiple Myeloma – Translational Medicine
Location: Santa Monica, CA
Duration: 12+ Months
Schedule: Monday – Friday, 8:00am – 17:00pm
Pay Rate: $43/hr. – $47/hr. 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
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.
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).