Research Scientist, Multiple Myeloma - Translational Medicine

VARITE is looking for qualified Research Scientist, Multiple Myeloma - Translational Medicine in Santa Monica, CA or Foster City, CA (Hybrid)

WHAT THE CLIENT DOES?

An American biotechnology company that develops cancer immunotherapy products with a primary focus on genetically engineered autologous CAR T cell therapy - a cell-based therapy which relies on chimeric antigen receptors and T cells.

WHAT WE DO?

Established in the Year 2000, VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850+ global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services.

Job Title

Research Scientist, Multiple Myeloma - Translational Medicine

Location

Santa Monica, CA 90404 or Foster City, CA 94404 (Hybrid)

Contract Duration

12 months with possible extension

Pay Range

$45.00/hr. to $47.35/hr. on W2

HERE’S WHAT YOU’LL DO

Summary

• 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

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)

BENEFITS

We offer a comprehensive benefits package designed to support the health, well-being, and financial security of our employees and their families.

Eligible employees may receive

• Health Insurance: Medical, dental, and vision coverage
• Retirement Plans: Participation in a company-sponsored retirement savings plan.
• Legal Service Plans: Offering access to attorneys for legal advice and representation.

If this opportunity interests you, please respond by clicking on EasyApply.

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VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.