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


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

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Other Job Details:

  • Eligible for Employee Referral Bonus

  • Eligible for Relocation Package

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