Biomarker Clinical Assay Lead Manager

Pfizer•San Diego, CA

2d•Hybrid

About The Position

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.

Requirements

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 OR BA with 4+ 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

Nice To Haves

CRO management and outsourcing engagement expertise
PhD or MS degrees.

Responsibilities

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 and 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 associated report, 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

Benefits

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
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
health benefits to include medical, prescription drug, dental and vision coverage

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