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New Haven PCRU Biomarker Laboratory Head

Company: Pfizer
Location: New Haven
Posted on: September 13, 2020

Job Description:

New Haven PCRU Biomarker Laboratory Head United States - Connecticut - New Haven

ROLE SUMMARY

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.

ROLE RESPONSIBILITIES

Sets objectives and manages multiple projects and on-going work activities of high complexity within the Global PCRU laboratories

Possesses appropriate credentials to lead a CLIA-accredited laboratory.

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 operation.

Exhibits a business expertise in the understanding of CAP and CLIA regulations and the ability to implement compliance in a high complexity laboratory.

Highly developed communication skills that allows knowledge sharing of scientific projects across multiple groups.

Ability to implement PCRU strategy and establish business priorities.

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 staff.

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 effectiveness.

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 this work.

Assures that all aspects of biomarker delivery meet regulatory expectations.

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 bioanalytical reports.

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.

BASIC QUALIFICATIONS

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, immunology, etc.).

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 regulated bioanalysis.

PREFERRED QUALIFICATIONS

Post-doctoral fellowship in Clinical Chemistry preferred.

Ability to understand disease biology and how it applies to biomarker development.

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, etc.)

Laboratory management, instrument lifecyle, and instrument validation requirements.

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

#LI-PFE

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you 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

Posted 2 Days Ago

Full time

4789959

About Us Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

Keywords: Pfizer, New Haven , New Haven PCRU Biomarker Laboratory Head, Other , New Haven, Connecticut

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