Job description

Internal Title: Research Scientist, Multiple Myeloma - Translational Medicine Schedule: M-F 8:00-17:00 Job Description Summary 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, 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)

Requirements

Must-haves

Internal Title: Research Scientist, Multiple Myeloma - Translational Medicine
Schedule: M-F 8:00-17:00
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

Nice-to-haves

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

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