Pfizer IHC Assay Validation and Outsourcing in Remote, North Carolina
As a member of the Translational Oncology, Translational Sciences group, the position plays a critical role in executing Translational Oncology Biomarker strategies through scientific technical oversight and management of external and internal partners involved in the implementation of clinical trial biomarker sample analyses. This individual will bring expertise to the team in the area of Immunohistochemistry assay establishment and use and serve as a subject matter expert when interacting with vendors utilizing this platform.
This position can be based at our La Jolla, CA site or remote.
Leads biomarker data management activities in support of early oncology clinical trial portfolio.
Functions as subject matter expert for IHC platform assays across the portfolio.
Provides bio-analytical assay and operational expertise to Study Teams to ensure delivery of high-quality clinical biomarker data.
Provides operational support to other Biomarker Clinical Assay Leads to ensure timely study start up and study close out activities.
Prepares and reviews bioanalytical reports: contributes to regulatory submissions and responds to regulatory queries when needed.
Key point of contact with internal labs, external vendors, and academic clinical laboratories, with oversight responsibilities for agreements, work plans, budget and invoices, assay transfer, assay validation, sample analyses, data transfers and overall data quality.
Provides technical support for selection, qualification and periodic audits of external laboratories supporting clinical trial biomarker assays.
Partners with internal partners to ensure appropriate biomarker sample handling and processing steps are appropriately described in the clinical trial Laboratory Manual.
Contributes to the process improvement initiatives.
Maintains up-to-date knowledge of biomarker assay technologies and clinical laboratory standards, regulatory guidance, and compliance
PhD with 2+ years of relevant experience or M.S./B.S. with 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. RNAseq, NanoString, NGS, IHC, PCR, FISH, flow cytometry, other cell based and circulating biomarker technologies).
Expertise in IHC assay establishment, troubleshooting, validation and sample analysis.
Demonstrated experience with clinical laboratory regulatory and compliance requirements, and hands-on knowledge of global regulatory requirements including GLP, GCP and the clinical trial process.
Assay problem solving and analytical skills; ability to resolve technical issues that may arise during method development, assay validation and sample analysis.
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
Highly effective verbal and written communication skills.
If remote, must be able to travel up to 5% to the La Jolla site and to vendor locations
- Additional certification in Clinical Laboratory Sciences, experience in biomarker analyses and clinical laboratory testing in Oncology, Molecular Oncology, or Hematopathology.
OTHER JOB DETAILS
Eligible for Relocation Package
Eligible for Employee Referral Bonus
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.