Biomarker Clinical Assay Lead (Manager)

ROLE SUMMARY

As a member of our Oncology team, you will play a critical role in supporting Translational Science Operations strategies, through scientific technical oversight and management of external and internal partners involved in the implementation of clinical trial biomarkers sample analyses.

ROLE RESPONSIBILITIES 

• Provide biomarker bioanalytical 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, e.g., 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.

• Contribute to the biomarker CRF selection/development; lead the data transfer specific development with internal/external biomarker laboratories and internal data management group.

• Lead and contribute to the ongoing development of best practice processes and templates. Lead / sponsor sub-teams or initiatives toward continuous improvement. Provide strategic direction as it relates to internal, cross-function and external continuous improvement efforts.

• Maintain up-to-date knowledge of biomarker assay technologies and clinical laboratory standards, regulatory guidance (e.g., GLP, GCLP), and compliance.

• Provide subject matter expertise and guidance to colleagues.

• Lead / co-lead complex pilot studies and projects across preclinical Pfizer Oncology enterprise.

MINIMUM QUALIFICATIONS 

• PhD with 2+ years 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) OR

• MS with 4+ years 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) OR

• BS with 7+ years 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)

• Strong track record of publications and/or conference presentations demonstrating recognized subject matter expertise in one or more of these areas: IHC, Flow Cytometry, and Molecular Oncology (NGS) assays

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

• Strong verbal and written communication skills

PREFERRED QUALIFICATIONS 

• Experience with clinical or companion diagnostics

• Experience training Manager level colleagues.

• Extensive CRO management and outsourcing engagement experience

• Experience with Oncology specialty platforms, Molecular Oncology, or Hematopathology

• Clinical Lab Science (CLS) or American Society of Clinical Pathologist (ASCP)  certification

  
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.
 

  
Work Location Assignment: On Premise

The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is