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ROLE SUMMARYAs a member of the Pfizer Oncology Clinical Research Lab, this individual will be responsible for the discovery, development, validation, and implementation of clinical pharmacodynamic and mechanistic biomarker assays in support of clinical development of anti-cancer agents.ROLE RESPONSIBILITIES
Discover, develop, optimize, and implement PD and POM biomarker assays to enable and support POM decisions.
Develop, validate and execute biomarker assays to support Phase I/II clinical studies
Design and execute preclinical studies in relevant models and/or human samples to enable validation of clinically translatable biomarker approaches.
Explore novel concepts and innovative technologies to expand the group's biomarker discovery capabilities.
Meet appropriate regulatory guidelines for assessment of clinical tissue specimens
Ensure all tasks and responsibilities are carried out according to scientific and ethical standards.
Interface with colleagues in development teams and provide input in sample logistics in clinical protocols. Provides bio-analytical assay technical and operational expertise to Study Teams to ensure delivery of high quality clinical biomarker data.
Responsible for supporting and performing clinical trial assays and coordinates with internal partners to ensure appropriate biomarker sample handling and processing steps are appropriately described in the clinical trial Laboratory Manual.
Prepares and reviews bioanalytical reports: contributes to regulatory submissions and responds to regulatory queries when needed.
Participate, contribute and thrive in an interactive, multi-functional team oriented culture
BASIC QUALIFICATIONS
Ph.D., (>1 year), M.S., (>5 years) or B.S. (>8 years) degree in a relevant scientific field with a focus on Cancer biology, cancer genetics, Biotechnology, molecular biology, immuno-oncology
Demonstrated Industry or clinical research experience in biomarker assay development, assay validation with a focus on cancer biology and biomarkers, employing a broad range of NGS platform technologies (e.g. RNA-Seq, Whole genome, Whole Exome, Targeted Sequencing, ChIPSeq, ATAC-Seq, NanoString/HTG analysis of mRNA, PCR, ddPCR, cfDNA, RT-PCR, Single Cell Sequencing and other molecular biology based biomarker technologies. An understanding on Western blotting, IHC, Flow Cytometry, plate based assays is a plus).
Experience working with human samples, including various types of tumor specimens, blood, and skin samples.
Ability to work with large, multi-omic data sets and familiar with techniques for exploring associations of biomarkers with clinical outcomes. Must have broad experience with preparing NGS libraries and data generated by high-throughput molecular assays, with a particular emphasis on next-generation sequencing technologies.
Understanding of clinical laboratory regulatory and compliance requirements and knowledge of global regulatory requirements including GCLP, GLP, GCP, CAP/CLIA is a plus.
Demonstrated record of understanding of cutting edge research as evidenced by first or senior authored publications in top tier journals
Ability to resolve technical issues that may arise during method development, assay validation and sample analysis. Be able to distill complex issues and clearly articulate solutions.
Must have understanding of the statistical principles behind current best practices in the field, as well as experience with biomarker characterization and discovery
Demonstrated ability to think strategically and creatively while contributing to multiple projects.
Outstanding ability to work productively in a collaborative, multi-disciplinary and diverse team setting. Ability to collaborate, lead, influence and motivate others
Highly effective good verbal and written communication skills.
Ability to demonstrate effectiveness and growth in a fast-paced and dynamic environment
Demonstrated ability to think strategically and creatively while contributing to multiple projects, thrive in a highly collaborative, multi-disciplinary team setting; highly effective verbal and written communication skills.
PREFERRED QUALIFICATIONS
Experience with both cell-autonomous and tumor microenvironment mechanisms.
Demonstrated ability to thrive in matrix organizations.
Familiarity with state-of-the-art technologies applicable to cancer biomarker or immune response analysis such as immunohistochemistry, immunofluorescence, flow cytometry, and digital image analysis.
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Relocation eligible
Eligible for employee referral bonus
N (Other) (United States of America)Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Vacancy expired!