Biomarker Clinical Assay Lead, Translational Oncology
What You Will Achieve
As a member of our Translational Oncology team, you will play a critical role in executing Translational Oncology Biomarker strategies through scientific technical oversight and management of external and internal partners involved in the implementation of clinical trial biomarker sample analyses. You will bring expertise to the team in the area of clinical Flow Cytometric assay development, validation, transfer and serve as a subject matter expert when interacting with vendors utilizing this platform.
How You Will Achieve It
- Serves as a member of the clinical study team and biomarker bioanalytical subject matter expert for executing clinical study setup and conduct, contributing to the study protocol development and review (schedule of assessments), developing and implementing bioanalytical strategies and assays, and delivering regulatory compliant data and reports within program timelines.
- Supports the clinical trial conduct including development and review of documents and processes such as CRF and data setup, clinical site lab manual, analytical lab manuals, SRFs, sample management & reconciliation, bioanalytical study planning & reporting, budgeting and invoicing, compliance with clinical SOPs & policies, and regulatory inspection readiness & conduct.
- Leads biomarker data management activities in support of early oncology clinical trial portfolio.
- Leads development of novel complex fit-for-purpose biomarker next-generation platforms (e.g. mass cytometry, high dimensional spectral flow).
- Troubleshooting & resolution of complex technical & logistical issues with vendors and study teams.
- Functions as subject matter expert for flow cytometric assays across the early stage oncology portfolio.
- Provides bio-analytical assay and operational expertise to Study Teams to ensure delivery of high-quality clinical biomarker data.
- Provides operational support to other Biomarker Clinical Assay Leads to ensure timely study start up and study close out activities.
- Prepares and reviews bioanalytical reports
- Contributes to regulatory submissions and responds to regulatory queries when needed.
- Key point of contact with internal labs, external vendors, and academic clinical laboratories, with oversight responsibilities for contracts, agreements, work plans, budget and invoices, assay transfer, assay validation, sample analyses, data transfers and overall data quality.
- Provides technical support for selection, qualification and periodic audits of external laboratories supporting clinical trial biomarker assays.
- Liaise with internal partners to ensure appropriate biomarker sample handling and processing steps are captured in clinical trial Laboratory Manual.
- Contributes to the process improvement initiatives including but not limited to CAPA implementation and participation in clinical site training activities
- PhD with a minimum of 2 years of relevant experience or M.S. with 5 years/B.S. with 7 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. RNAseq, NanoString, NGS, IHC, PCR, FISH, flow cytometry, other cell based and circulating biomarker technologies).
- Experience in flow cytometry assay establishment, troubleshooting, validation and sample analysis.
- Demonstrated experience with clinical laboratory regulatory and compliance requirements, and hands-on knowledge of global regulatory requirements including GLP, GCP and the clinical trial process.
- Assay problem solving and analytical skills; ability to resolve technical issues that may arise during method development, assay validation and sample analysis.
- Experience working productively in a collaborative, multi-disciplinary/diverse team setting
- Highly effective verbal and written communication skills.
- Certification in Clinical Laboratory Sciences
- Experience in biomarker analyses and clinical laboratory testing in Oncology, Molecular Oncology, or Hematopathology
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.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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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.Medical