Pfizer Biomarker Clinical Assay Lead Manager in La Jolla, California
Provide bio-analytical assay technical and operational expertise to Study Teams to ensure delivery of high quality clinical biomarker data within Global Product Development.
Support assay development and timely availability of fit-for-purpose 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 lab., 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, within one or multiple therapeutic areas including Oncology, Rare Diseases, Gene Therapy, and Inflammation.
Well Qualified candidates with B.S. and M.S will be considered based on experience in biomarker analyses and clinical laboratory testing in Rare Disease, Inflammation, Gene Therapy, Oncology, Molecular Oncology, or Hematopathology.
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
Certification in Clinical Lab Science (CLS) or American Society of Clinical Pathologist (ASCP) is a plus.
CRO management and outsourcing engagement expertise preferred
Other Job Details:
Eligible for Relocation Package
Eligible for Employee Referral Bonus
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