Job Description
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.
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
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
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)
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Santa Monica, CA |
| Industry | Computer/IT Services |
| Salary | $40–$45 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
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