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Pfizer Inc. Biomarker Clinical Assay Lead, Manager in Denver, Colorado

ROLE SUMMARYAs a member of the Clinical Assay Group within Global Clinical Pharmacology,Biomarker Clinical Assay Lead will play a critical role in supporting clinicalstrategies in all stages of drug development and post marketing activitiesthrough scientific and technical leadership, oversight and management ofexternal and internal partners involved in delivering quality, timely, andregulatory compliant biomarker analytical assays and data.ROLE RESPONSIBILITIESServes as a member of the clinical study team and bioanalytical subject matterexpert for executing clinical study setup and conduct, contributing to thestudy protocol development and review, preparing submissions, addressingregulatory queries, developing and implementing bioanalytical strategies andassays, and delivering regulatory compliant data and reports within programtimLeads development of novel complex fit-for-purpose biomarker methodologies,troubleshooting and resolution of complex technical and logistical issues withvendors and study teams.Identifies technology/capabilities gaps and proposes mitigationstrategies, including development of novel technical capabilities withvendors.Scientifically evaluates complex data (i.e. evaluates aberrant results anddata trends), anticipates and corrects potential issues, and able toappropriately guide study teams through complex issues resolution.Leads and oversees fit-for-purpose biomarker assay lifecycle management fromearly stage to registration encompassing analytical development and methoddesign, validation, data quality review, corresponding sample analysesand reporting to meet evolving program objectives and regulatory expectations.Guides and leads study teams with respect to the selection and execution ofthe analytical strategy.Functions as key point of contact with external and internal laboratories andleads selection, qualification, performance evaluation, periodic visitsand audits of CRO laboratories conducting clinical biomarker assays.Supports the clinical trial conduct within scope of the Clinical Assay Groupresponsibilities, including development and review of documents andprocesses such as CRF and data setup, clinical site lab manual, samplemanagement and reconciliation, bioanalytical study planning and reporting,budgeting and invoicing, compliance with clinical SOPs and policies, andregulatory inspection readiness and conduct.Contributes to the development of Best Practices processes, templates, andpolicies.Maintains up-to-date knowledge of current and novel biomarker assays andtechniques, global regulatory guidance's and expectations, and industrybest practices.BASIC QUALIFICATIONSPhD with experience in Clinical Laboratory Sciences, Molecular biology orrelated fields with 3+ years' experience in biomarker assay development,validation, and clinical laboratory sample analyses.Master's degree with 5+ years OR Bachelor's degree with 7+ years'experience in in biomarker assay development, validation, and clinicallaboratory sample analysis.Certification in Clinical Lab Science (CLS) or American Society ofClinical Pathologist (ASCP) is a plus.Demonstrated knowledge and experience with development, validation andtroubleshooting and use within clinical trials, of broad range of platformtechnologies (e.g. LBA, NGS, IHC, PCR, FISH, flow cytometry,other cell based and circulating biomarker technologies).Demonstrated ability to understand disease biology and how it applies tobiomarker in multiple therapeutic areas including Rare Diseases, GeneTherapy, and Inflammation.Strong understanding of critical reagent generation and lifecycle management.In depth knowledge and ability to provide interpretation of GxP, CAP andCLIA regulations governing conduct of clinical trials and regulatory guidancesand expectations relevant to regulated biomarker bioanalysis as to differenttechnologies and context of use.Demonstrated ability to think strategically, work effectively in a highlymatrixed environment, and execute multiple projects si

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