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Biomarker Clinical Assay Lead, Sr Manager

La Jolla, California
Closing date
Jul 28, 2021

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Health Sciences, Medicine
Position Type
Full Time
Job Type
Organization Type
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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 biomarkers sample analyses.


  • Provide bio-analytical assay technical and operational expertise to Study Teams to ensure delivery of high quality clinical biomarker data

  • Lead novel assay development and timely availability of fit-for-purpose oncology clinical biomarker assays to clinical Study Teams. Troubleshoot/resolve complex technical/logistical issues at vendors. Evaluate complex data critically, i.e. evaluates aberrant results, data trends and guide team in broader interpretation of data.

  • 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.

  • Lead and 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

  • Lead and contribute to the ongoing development of Best Practices processes and templates. Lead/sponsor subteams or initiatives toward continuous improvement. Provide strategic direction as it relates to internal, cross-line and external continuous improvement efforts.

  • Maintain up-to-date knowledge of biomarker assay technologies and clinical laboratory standards, regulatory guidance and compliance.

  • Provide subject matter expertise and guidance to colleagues. May have responsibility for dotted/direct line management of staff.

  • Leads/co-lead complex pilot studies and projects across Oncology enterprise

  • Provide SME support and leadership to internal organizational initiatives


  • Bachelors Degree with 10+ years OR Masters Degree with 7+ OR PhD/equivalent with 4+ of industry or clinical laboratory experience in Oncology 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).

  • Recognized as an SME for at least one or more analytical area of expertise especially IHC, Flow Cytometry, and Molecular Oncology (NGS) assays based on record of publication and/or conference presentations.

  • Certification in Clinical Lab Science (CLS) or American Society of Clinical Pathologist (ASCP) is a plus with expertise in Oncology specialty platforms, Molecular Oncology, or Hematopathology

  • Extensive knowledge of clinical laboratory regulatory and compliance requirements (GCLP, CAP, CLIA, etc.) for fit for purpose biomarker assay oversight within oncology clinical trials.

  • Track record of strategic thinking and creativity while contributing to multiple projects simultaneously

  • Worked productively in a collaborative, multi-disciplinary and diverse team setting

  • Prior expertise in training manager level colleagues.

  • Extensive CRO management and outsourcing engagement expertise

  • Highly effective verbal and written communication skills

  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.


  • Eligible for relocation package

  • Eligible for employee referral bonus


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.

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.


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