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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.
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 the company 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 the company 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
• 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.
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.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company 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. the company 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. the company is an E-Verify employer.
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