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Biomarker Assay Specialist/ Manager

Pfizer


Location:
San Diego, CA
Date:
11/02/2017
2017-11-022017-12-03
Pfizer
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Job Details

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







**Qualifications**







Educational Background:



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.







Prior Experience:







+ 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**



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.







**Sunshine Act**



Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.







**Additional Offer Details:**







+ Last Date to Apply for Job: October 27, 2017



+ This job is Pfizer Exempt US/PR Grade: 008



+ Internal Candidate Identified







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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