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 eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

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. This position requires permanent work authorization in the United States.

Medical