New Haven PCRU Biomarker Laboratory Head United States -
Connecticut - New Haven
The Biomarker Laboratory Head is a Director level position and
is accountable all laboratory resources (staff, equipment,
supplies) and leads the assay development and validation for novel
biomarkers and for technology transfer of existing assays from WRD
(e.g., Early Clinical Development, Oncology) and non-Pfizer
sources. This person will have a very close working relationship
with the Pfizer global Clinical Assay Group (CAG) to support
biomarker identification and application in study design to drive
portfolio decisions. Supports and/or leads electronic and digital
solutions for biomarker data management. Leads and oversees
biomarker development from early stage to registration,
encompassing analytical development, method design, validation,
data quality review, sample analyses, and report generation. Serves
as a scientific expert in ligand binding, clinical pathology, and
molecular biology biomarkers. Possesses the appropriate credentials
to lead a CLIA-accredited laboratory. May assume leadership of the
Global PCRU Laboratories in New Haven and Brussels in absence of
the Global Laboratory Services Lead.
Sets objectives and manages multiple projects and on-going work
activities of high complexity within the Global PCRU
Possesses appropriate credentials to lead a CLIA-accredited
Manages and leads people, technological and financial resources
in the PCRU Laboratory group.
Considered a subject matter expert and provides
technical/functional expertise to the Global PCRU regarding
biomarker development and clinical pathology compliance and
Exhibits a business expertise in the understanding of CAP and
CLIA regulations and the ability to implement compliance in a high
Highly developed communication skills that allows knowledge
sharing of scientific projects across multiple groups.
Ability to implement PCRU strategy and establish business
Accountable for development of management skills and diverse
talent within the Biomarker group.
Serves as back-up lead for Safety Laboratory when Global
Laboratory Services Lead is unavailable.
Leads and oversees biomarker development from early stage to
registration, encompassing analytical development, method design,
validation, data quality review, sample analyses, and report
generation to support regulatory filings. Leads team of biomarker
Provides expertise regarding clinical chemistry and
disease-relating biomarkers to study teams and PCRU staff.
Communicates with medical providers regarding critical assay
values and development of new assays to improve PCRU efficiency and
Possesses and maintains an up-to-date knowledge of current and
novel mass spectrometry, ligand binding, flow cytometry, and
molecular biomarkers and associated instrumentation for conduct of
Assures that all aspects of biomarker delivery meet regulatory
Develops and maintains quality processes and SOPs in the
laboratories, ensuring that all temperature records, calibrations
and certifications of instruments and equipment are sustained.
Develops and enforces policies to assure biological, chemical,
and general safety in the labs.
Leads Biomarker quality oversight for biomarker development and
delivery. Provides instruction and guidance on quality issues and
serves as a resource for resolution of deviations and development
of effective CAPA.
Generates study budgets for biomarker development.
Create a strong partnership and communication with the Clinical
Assay Group (CAG), Early Clinical Development and Oncology to
effectively transfer biomarker assays within the Pfizer
organization and meet project team timelines.
Assists in CLIA, CAP, FDA, and PMDA site audits.
Supports utilization of Cerner Helix and e-Workbook for
Biomarker data storage and archival.
Responsible for final Biomarker validation plans and
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.
8- 10 years of professional experience in a clinical,
diagnostic, pharmaceutical, or public health laboratory, including
four years in a supervisory capacity.
Possesses a doctorate in chemical, physical, biological or
laboratory sciences (e.g. clinical chemistry, clinical pathology,
Certified by one the following boards approved by Health and
Human Services: American Board of Clinical Chemistry (ABCC),
American Board of Bioanalysis (ABB), American Board of Medical
Laboratory Immunology (ABMLI), or National Registry of Certified
Chemists (NRCC; PhD level only).
Meets qualifications/conditions of employment: Under federal
law, the incumbent must meet personnel requirements for a high
complexity testing director (42 CFR 493.1443), Clinical Laboratory
Improvement Amendments of 1988 (CLIA).
Working knowledge of GxP,CAP and CLIA regulations governing
conduct of clinical trials and regulatory guidance’s relevant to
Post-doctoral fellowship in Clinical Chemistry preferred.
Ability to understand disease biology and how it applies to
Demonstrated ability to think strategically, work in a matrixed
environment, and execute multiple projects simultaneously.
Hands-on experience with the development, validation and
troubleshooting of fit-for-purpose biomarker methods using a
spectrum of methodologies.
Experience with regulatory inspections (CLIA, CAP, FDA,
Laboratory management, instrument lifecyle, and instrument
Working knowledge of laboratory information systems and/or
software systems for biomarker data documentation.
Additional Job Details-
Last Date to Apply for Job: 8/19/2020
Additional Location Information: New Haven, CT
Relocation support available
Eligible for Employee Referral Bonus
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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.
Research and Development
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