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Laboratory Services Director, Clinical Research (PCRU

Pfizer


Location:
New Haven, CT
Date:
04/17/2018
2018-04-172018-05-18
Pfizer
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Job Details

**POSITION SUMMARY**



The Laboratory Services Director is accountable all laboratory resources (staff, equipment, supplies)and leads the production analysis (e.g., chemistry, hematology, urinalysis) activities associated with ongoing studies conducted in PCRU-NH . This individual may lead assay development and validation for novel biomarkers and for technology transfer of existing assays from WRD (eg, Discovery Research, PDM) 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 in order to drive decisions.







**POSITION RESPONSIBILITIES**







+ Leads and manages all laboratory staff, for both the biomarker and safety laboratory operations and deliverables



+ In conjunction with Clinical Sciences staff, develops biological markers of pharmacodynamic and effect and disease models to support new drug development in humans and to support regulatory filings.



+ Leads the development, validation and performance of biomarker methods and routine clinical safety analyses to support the clinical development of drug candidates.



+ 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.



+ Assures accurate collection and processing of biological specimens to assure quality of analytical data.



+ In conjunction with the Medical Director and Groton Clinical Sciences, establishes policies on scientific and operational practices and assures exemplary scientific and ethical standard.



+ Assures compliance of all activities with applicable regulations and guidelines.



+ Delivers high quality, validates methods and laboratory data to Groton Clinical Sciences.



+ Recruits, trains, appraises and provides for career counseling / development of staff including continued competency.



+ Develops and maintains unit capability by assuring that facilities and equipment are properly maintained, validated, and periodically updated



+ Involved in the creation and implementation of global and local SOPs, ensuring staff are trained



+ Active member of the PCRU-NH Leadership Team and the extended Global PCRU Leadership Team



+ Develops solutions to highly complex problems within the CRU.



+ Interprets Division's strategy to establish business priorities that support and help to set long-term objectives for the PCRU-NH .



+ Assesses the PCRU-NH's talent to ensure strength for critical roles. Motivates direct and indirect reports and delivers results for the PCRU-NH and for Research and Business Units.



+ Contributes to the PCRU-NH knowledge management processes/systems.







**Supervision**







+ Staff: 12-25 Pfizer colleagues and up to 50 contingent workers



+ Tiers: 2-3.







**EDUCATION AND EXPERIENCE**







+ PhD in chemistry or the biomedical sciences preferred.



+ Certification by a relevant HHS-approved board (e.g., American Board of Bioanalysis/ ABB) preferred.



+ American Society of Clinical Pathology (ASCP) certification preferred



+ Previous direct work experience (10+ years) managing a laboratory in a health care or pharmaceutical setting; expected experience in analytical techniques and full knowledge of analytical validation procedures.







**TECHNICAL SKILLS REQUIREMENTS**







+ Previous direct work experience (10+ years) managing a laboratory in a health care or pharmaceutical setting; expected experience in analytical techniques and full knowledge of analytical validation procedures.



+ Experience with clinical trial operations



+ Significant track record of experience and accomplishment in clinical and/or research laboratory setting.



+ Demonstrated leadership ability and supervisory experience



+ Good interpersonal skills







+ Through knowledge of OSHA requirements related to safe operation of laboratories.



+ Thorough knowledge of clinical pharmacology and regulatory requirements (GCP, GLP, CLIA).



+ Experience leading teams and motivating direct and indirect staff



+ Proven ability to accept, accommodate and manage change in a fast-paced high-stress setting.







**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.







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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