This job is closed
Applications are no longer available for this announcement. Explore current related opportunities below.
Job description
Position: Research Scientist, Multiple Myeloma - Translational Medicine
Location: Santa Monica, CA 90404
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Hybrid
Shift: Monday - Friday From 8:00am To 05:00pm
Pay Rate: $40.00-$45.00/Hr
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.
Job Description:
Summary:
The Research Scientist will support biomarker and translational strategy for the clinical development of Clien'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 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
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)
TekWissen Group is an equal opportunity employer supporting workforce diversity.
#J-18808-Ljbffr
Worksite address
santa monica, CA, 90403, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.