Clinical Pharmacogenomics Laboratory Head (Sr. Principal Scientist)

Organization
Pfizer
Job Location
Groton, CT
Job Description

Role Description

Supporting clinical programs across all therapeutic area, including the novel modalities of gene
therapy and CAR-T approaches, the Clinical Pharmacogenomics lab is the single CLIA-qualified
internal laboratory for pharmacogenomic and gene expression analyses. Working closely with
clinical teams, the laboratory identifies clinical molecular testing assays necessary to ensure a
viable biomarker/diagnostics strategy (including target and safety markers) for early-stage
development projects to provide early proof of mechanism and signs of efficacy, whenever
possible.

Responsibilities

Is responsible for the overall direction, operation and administration of the Clinical
Pharmacogenomics (PGx) lab, including:

• Provides strategic plan for clinical pharmacogenomic laboratory, including program impact and
technology investments. Aligns the PGx Lab goals with Pfizer WRD Precision Medicine vision
and external industry trends.
• Identifies clinical molecular testing assays necessary to ensure a viable biomarker/diagnostics
strategy (including target and safety markers) for early-stage development projects, whenever
possible
• Has a thorough understanding of clinical trials including their requirements and associated
documents
- Protocols and Informed Consent Documents (ICD)
- Validated/Research/Exploratory assays
• Fosters networks with both internal and external contacts to promote Pharmacogenomics and
keeps abreast with changing dynamics and new technologies in the field.
• Oversees genotyping and gene expression assay development and validation to meet all
measurement criteria
• Provides scientific leadership in understanding and clinical testing of ADME polymorphisms of
functional significance for Pfizer's drug candidates
• Has a good understanding of laboratory regulations (CLIA, CAP and GCLP) needed for global
clinical trials.
• Ensures the Clinical PGx lab (including all clinical assays, instrumentation, and QA/QC
program) are in compliance with good clinical practice and company SOPs
• Responsible for the results of clinical tests performed in the lab. Review, interpret, and report
results to clinical teams on time, whenever applicable
• Recruits and trains laboratory staff; monitors competency and ensures personnel in-service
development for professional growth and certification

Requirements

Qualifications

• PhD or MD with 4 or more years working experience in human genetics, preferably with
experience in clinical trials and/or clinical diagnosis
• Experience supervising in a regulated environment, preferably CLIA.
• A thorough understanding of pharmacogenomics, genetics/genomics, technologies in
genotyping and gene expression, and regulations in both clinical diagnosis and clinical
laboratory operations
• Team player with excellent oral and written communication skills
• Demonstrates personnel, resource, and budget management expertise
• Experience in supervising laboratory staff
• Relevant board certification desired but not required.

PHYSICAL/MENTAL REQUIREMENTS

High intellect, able to work at computer and monitor for extended periods, travel from office
area to laboratories within the same building.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Primarily Groton based, with some travel to other sites (e.g. Boston and La Jolla) required.

How to Apply

To be considered for this role, please apply at www.pfizercareers.com by searching Job #1041341

About Our Organization

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone,
everywhere. Our colleagues have the opportunity to grow and develop a career that offers both
individual and company success; be part of an ownership culture that values diversity and where
all colleagues are energized and engaged; and the ability to impact the health and lives of
millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously
seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that
significantly improve their lives.

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