Pfizer Biomarker Assay Specialist, Senior Manager in La Jolla, California
As a member of the Oncology Clinical Assay Group within Pfizer Oncology, the successful candidate will play a critical role in supporting Translational Oncology strategies through scientific technical oversight and management of external and internal partners involved in the implementation of clinical trial biomarker sample analyses.
Provide bio-analytical assay technical and operational expertise to Study Teams to ensure delivery high quality clinical biomarker data
Support assay development and timely availability of fit-for-purpose oncology clinical biomarker assays to clinical Study Teams
Function as key point of contact with external commercial or academic clinical laboratories, as well as internal clinical labs, with oversight responsibilities for agreements, work plans,budget and invoices, assay transfer, assay validation, sample analyses, data transfers and overall data quality.
Provide technical support for selection, qualification and periodic audits of CRO laboratories supporting clinical trial biomarker assays.
Coordinate with Study Teams and clinical operations to ensure appropriate biomarker sample handling and processing steps are appropriately described in the clinical trial Laboratory Manual Contribute to the ongoing development of Best Practices processes and templates.
Maintain up-to-date knowledge of biomarker assay technologies and clinical laboratory standards, regulatory guidance and compliance
PhD or equivalent with experience in Clinical Laboratory Sciences, Oncology and Molecular biology.
Well qualified candidates with B.S. and 5 years' experience, M.S. with 3 years' experience, or additional certification in Clinical Laboratory Sciences, and significant experience in biomarker analyses and clinical laboratory testing in Oncology, Molecular Oncology, or Hematopathology will also be considered.
Minimum of five years of industry or clinical laboratory experience in biomarker assay development, assay validation and implementation within clinical trials, employing a broad range of platform technologies (e.g. NGS, IHC, PCR, FISH, flow cytometry, other cell based and circulating biomarker technologies);
Demonstrated understanding of clinical laboratory regulatory and compliance requirements
Demonstrated ability to think strategically and creatively while contributing to multiple projects simultaneously
Ability to work productively in a collaborative, multi-disciplinary and diverse team setting
Highly effective verbal and written communication skills.
EEO & Employment Eligibility
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Other Job Details:
Eligible for Employee Referral Bonus
Eligible for Relocation Package
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