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Aptask Global Workforce (AGW) is seeking a Research Scientist for a Hybrid position with a Global Biotechnology Company located in Santa Monica, CA. This is a 12+ month contract opportunity. The Research Scientist will support biomarker and translational strategy for the clinical development of 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, and communicate key findings cross-functionally is required.

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 established 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

Requirements:

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 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) Pay range: up to $47.35 per hour Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery. Benefits of working with ApTask Global Workforce include: Medical Dental Vision Sick Pay (for applicable states/municipalities) Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website https://www.agwtalent.com/. ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran. #INDAGW