Research Scientist, Multiple Myeloma - Translational Medicine

OverviewTekWissen 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 90404Duration: 12 Months Job Type: Temporary Assignment Work Type: HybridShift: Monday - Friday From 8:00am To 05:00pmSummary

Job Description

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 ResponsibilitiesDirects 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 LevelAdvanced scientific degree (i.e. MD, PharmD, PhD) and 3+ years in industry or Master's Degree and 5+ years of scientific experience orBachelor'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. TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes.TekWissen is an equal opportunity employer supporting workplace diversity.