Pfizer

Biomarker Clinical Assay Lead, Sr Manager

Employer
Pfizer
Location
La Jolla, California
Salary
Competitive
Posted
May 05 2021
Ref
4810894
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager
Why Patients Need You

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

What You Will Achieve

As a member of the Oncology Clinical Assay Group within Pfizer Oncology, the successful candidate will play a critical role in supporting Translational Oncology strategies through scientific technical oversight and management of external and internal partners involved in the implementation of clinical trial biomarkers sample analyses.

How You Will Achieve It

  • Provide bio-analytical 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, i.e. 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
  • Lead and contribute to the ongoing development of Best Practices processes and templates. Lead/sponsor subteams or initiatives toward continuous improvement. Provide
  • strategic direction as it relates to internal, cross-line and external continuous improvement efforts.
  • Maintain up-to-date knowledge of biomarker assay technologies and clinical laboratory standards, regulatory guidance and compliance.
  • Provide subject matter expertise and guidance to colleagues. May have responsibility for dotted/direct line management of staff.
  • Leads/co-lead complex pilot studies and projects across Oncology enterprise
  • Provide SME support and leadership to internal organizational initiatives


Qualifications


  • PhD or equivalent with 5+ years of experience in Oncology Clinical Laboratory Sciences. Well-qualified candidates with B.S and 10+ years of experience/M.S. with 8+ years in Oncology biomarker analyses will be considered. Certification in Clinical Lab Science (CLS) or American Society of Clinical Pathologist (ASCP) is a plus with expertise in Oncology specialty platforms, Molecular Oncology, or Hematopathology.

  • B.S. with minimum of ten 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).
  • Recognized as an SME for at least one or more analytical area of expertise especially IHC, Flow Cytometry, and Molecular Oncology (NGS) assays based on record of publication and/or conference presentations.
  • Extensive knowledge of clinical laboratory regulatory and compliance requirements (GCLP, CAP, CLIA, etc.) for fit for purpose biomarker assay oversight within oncology clinical trials.
  • Track record of strategic thinking and creativity while contributing to multiple projects simultaneously
  • Worked productively in a collaborative, multi-disciplinary and diverse team setting
  • Prior expertise in training manager level colleagues.
  • Extensive CRO management and outsourcing engagement expertise
  • Highly effective verbal and written communication skills.


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.

Relocation support available

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