Biomarker Clinical Assay Lead Manager

Position Summary

This position will sit within the Assay Development Group of the Companion Diagnostic Center of Excellence supporting clinical biomarker and diagnostic strategy development through scientific and technical oversight of biomarker and prototype diagnostic assays, clinical implementation and management of external and internal partners in oncology and other therapeutic areas. You will bring technical leadership to devise scientifically sound biomarker and diagnostic testing strategies, effective implementation of assays into clinical trials, and communicating data and program impacts to key stakeholders and project teams.

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

• Support assay development, validation and timely availability of fit-for-purpose Dx clinical biomarker assays to clinical Study Teams

• Function as key point of contact with external and internal clinical labs, with oversight responsibilities for agreements, work plans, budget and invoices, assay development, transfer, validation and associated report, sample analyses and data transfers and overall data quality

• Provide technical support for selection, qualification and periodic audits of bioanalytical laboratories supporting oncology clinical trial biomarker and Dx assays as appropriate

• Collaborate with Study Teams to ensure appropriate biomarker and Dx sample handling and processing steps are appropriately performed during clinical trials

• Serve as subject matter expert for biomarker and Dx testing technologies (NGS, PCR, IHC flow cytometry, immuno-assays etc)

• Collaborate with Asset Teams to manage the timely testing of clinical trial samples and the analysis and reporting of the associated data

• PhD in a relevant scientific field (e.g. pathology, immunology, oncology, molecular biology, genetics)
  OR

• MS in a relevant scientific field (e.g. pathology, immunology, oncology, molecular biology, genetics) with 2+ years of relevant experience

• Experience with the research and development of biologic therapeutics, biomarker and Dx assay development, validation and execution in clinical trials

• Experience and expertise in biomarker selection trials

• An understanding of translational approaches as applied to clinical trial design and regulatory processes, proof-of-concept studies, and the implementation of biomarkers and Dx

• Development, validation, and implementation of a broad range of platform technologies within clinical trials (e.g. NGS, IHC, PCR, FISH, flow cytometry, other cell based and circulating biomarker technologies)

• Demonstrated understanding of clinical laboratory regulatory and compliance requirements (GLP, GCP, GCLP, CLIA, CAP)

• Demonstrated ability to think strategically and creatively while contributing to multiple projects simultaneously

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

• Excellent communication and organizational skills; able to convey complex scientific and business issues to devise, reach agreement on, and implement solutions

• Experience collaborating, leading, influencing, and motivating others

• CRO management and outsourcing engagement expertise

• Last Date to Apply for Job:
  January 30th

• Work Location Assignment:
  Hybrid

• No relocation support available

The annual base salary for this position ranges from $106,000 to $171,500. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15% of the base salary and eligibility to participate in our share-based long-term incentive program. We offer comprehensive benefits including health, retirement and time-off programs. Benefits vary by location. Relocation assistance may be available based on business needs and eligibility.

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. If you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your information may be reported to the government. For questions, contact your Talent Acquisition representative.

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 is an E-Verify employer. This position requires permanent work authorization in the United States.

Pfizer endeavors to make  accessible to all users. For accessibility accommodations during the application process, please contact dis