Pfizer

Scientist, Clinical Biomarker Development

Employer
Pfizer
Location
Groton, Connecticut
Salary
Competitive
Posted
November 18 2020
Ref
4794250
Position Type
Full Time
Organization Type
Pharma
Position Purpose

  • The Regulated Clinical Biomarker/Flow Cytometry group works with clinical and translational teams across Pfizer research units to develop and implement complex flow cytometry-based biomarker assays and supportive translational/mechanistic studies for early phase clinical projects in a GCLP environment.
  • This position is responsible for execution of scientific research and/or scientific strategies in a biomarker/biomeasure focused flow cytometry laboratory.
  • This scientist will provide technical and scientific support for biomarker data using flow cytometry (FACs), cell imaging and related technologies for both non-regulated and regulated clinical biomarker studies supporting Pfizer drug candidates.
  • This scientist will interact with inter-departmental colleagues, clinical and translational teams, research units and contract research organizations in a matrixed environment.


Primary Responsibilities

  • Responsible for clinical flow cytometry biomarker assay development and validation, data generation and analysis, QC, data interpretation and communication to project teams to enable appropriate decision making.
  • This position will participate with Early Clinical Development (ECD) teams and research units in a matrix environment.
  • The person will demonstrate experience in the delivery of flow cytometry and cell imaging-based biomarkers/biomeasures in clinical studies, and have strong knowledge of biological systems, cellular functions and concepts in immunology to enable Pfizer discovery and development objectives.
  • Responsible for developing partnerships in a matrix environment, influencing project strategies, and providing expertise in technology development and implementation.
  • This role will participate in all phases of FACs laboratory operations including technology evaluations, the development of sample preparation, separation and detection methods, data analysis, interpretation, reporting and follow up discussions with the project teams on utilizing the data in appropriate decision making.
  • All colleagues in this role are responsible for maintaining regulatory compliance appropriate for clinical study execution including all proscribed training as found in ECD SOPs and training transcripts. This includes knowledge, training and understanding of GLP/GCP guidance for execution of preclinical and clinical studies supporting Pfizer portfolio projects as applicable.
  • Participate in continuous improvement of scientific and regulatory processes via update/creation of SOP's, design and implementation of laboratory and study based processes, and development of best practices for bioanalytical data generation.
  • Responsible for QC and peer review of raw data, results, and final reports from other collegues within the regulated group (depending on level of training). Additionally responsible for participation in internal and external audits providing required information to auditors as needed.
  • May also participate/respond to internal audit findings on assigned projects.
  • Occasional weekend work for processing clinical samples should be anticipated.


Experience, Education

  • Bachelor's Degree or equivalent experience in chemistry, biochemistry, biology or related discipline with over 5+ years' experience in drug development and regulatory compliance within the pharmaceutical industry.
  • Extensive experience in immune cell function and phenotypic analysis using a variety of assays.
  • Knowledge and experience of global regulatory requirements as well as industry guidance as they relate to GCLP.
  • Excellent oral and written communication skills
  • Ability to deal with project and organizational change while supporting the organization


Requirements

  • The requirements for the position include standing and sitting for extended periods of time, as well as bending and lifting.
  • The ability to perform mathematical calculations and ability to perform complex data analysis is required.
  • Occasional weekend work for processing clinical samples should be anticipated.


Other Job Details:
  • Last Date to Apply for Job: October 20, 2020
  • Eligible for Employee Referral Bonus: YES


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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.

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