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DSRD Global Clinical Pathology Senior Scientist

Pfizer


Location:
Groton, CT
Date:
01/26/2018
2018-01-262018-03-09
Pfizer
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Job Details

This position will reside within the Global Clinical Pathology laboratory a section of the Global Biomarker Laboratories within Drug Safety Research and Development The candidate will contribute to the Global DSRD Biomarker Clinical Pathology group to enable effectiveness across the DSRD Global Biomarker organization. The role will provide laboratory support for the Global Clinical Pathology laboratory including routine clinical pathology and investigative biomarker support to support both efficacy and safety evaluation of drug candidates for discovery, pre-clinical, and clinical studies. Routine clinical pathology analysis involves hematology, clinical chemistry, coagulation, immunoassay and urinalysis.







**Role Responsibilities**







+ The major duties & responsibilities will include but are not limited to:



+ The candidate is responsible for generation of hematology, clinical chemistry, urinalysis, coagulation, immunoassay and novel assay development data in support of both safety and efficacy assessment of pharmaceutical drug candidates in compliance with GLP/GCLP and College of American Pathologists (CAP) regulatory standards as applicable within a Clinical Pathology laboratory.



+ Other responsibilities of the candidate will include ensuring the quality of raw data, contributing to methodology development for new biomarkers, contributing to technology development, author technical documents such as validation plans/memos, SOPs, User Guides, and memos as required.



+ Exposure to new methods development such as flow cytometry and plate base assays is possible based upon individual experience and knowledge.



+ Experience with a laboratory informatics data collection system is required.



+ Candidate will develop/validate new methodologies or applications, process and evaluate data from samples for multi-site studies, evaluates data including study samples and quality control samples, participates in routine equipment maintenance and instrument and/or assay troubleshooting, provides data collation, summarization, QC evaluation, and archiving as required.



+ The candidate contributes to biomarker assay validation, including planning, data collection, interpretation, and document authorship to support GLP and non-GLP multispecies safety studies as well as Pfizer human clinical trials.



+ The candidate assures that laboratory activities meet quality standards such as Pfizer policies, SOPs, Environmental Health and Safety and departmental guidelines.



+ The candidate enables DSRD Biomarker support of Pfizer Phase I and II clinical trials including project management, delivery of data, communication with teams, and preparation for GCLP QA audits, enables the strategy of Clinical Translation in partnership with the DSRD Clinical and Translational lead supporting initiatives such as the Bio-sample Retention Strategy for Safety team.







**Qualifications**







+ B.S. /B.A. in Medical Technology or related science related field with greater than 10 years of experience within a Clinical Pathology laboratory within a pharmaceutical company, CRO, hospital or diagnostic company with knowledge of Good Laboratory Practices, data collection laboratory informatics systems, and data processing applications



+ Candidate assures that laboratory activities meet quality standards such as Pfizer policies, SOPs, Environmental Health and Safety and departmental guidelines, ability to handle multiple projects simultaneously, maintaining a high quality of data and timely delivery of results



+ Well organized, self-motivated, detail oriented, and has the ability to work and effectively communicate within a team environment



+ Excellent oral and written communication skills and ability to multitask, and highly motivated and enthusiastic scientist with proven record of independent analytical thinking and collaboration, ability to relish change, energize others and are passionate about work and have experience with Cerner laboratory information system and laboratory based workflows.



+ Thorough understanding of the processes associated with pre-clinical and clinical study coordination and data management



+ Knowledge of multiple scientific disciplines that allow the collaboration with other sections such as Immunotoxicology, general toxicology, safety pharmacology, investigative toxicology or other disciplines



+ Ability to handle multiple projects simultaneously, maintaining a high quality of data and timely delivery of results







**PHYSICAL/MENTAL REQUIREMENTS**



The position requires performing a range of laboratory work and therefore the colleagues must be able to wear appropriate PPE and physically perform the technical procedures required. Standing, sitting, lifting up to 40lbs (on occasion), pipetting and other general lab tasks as required by the position are required.







**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



Travel to Global US sites or meetings as required







**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.







**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.







Additional Job Information:







+ This role is eligible for relocation







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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