DSRD Global Clinical Pathology Laboratory Lead

Pfizer
Groton, Connecticut
Competitive
June 24 2022
4835063
Full Time
Pharma
ROLE SUMMARY

The Clinical Pathology Laboratory lead is a leadership role within the Global Pathology discipline with a single point of accountability for the laboratory operations to support clinical pathology discipline. The leader is accountable to provide global laboratory and scientific leadership and supervision, act as the main point of accountability for all technical, scientific issues and manage all clinical pathology testing (hematology, biochemistry, coagulation, urinalysis, immunoassays) in support of the Pfizer preclinical and clinical portfolio. In close collaboration with the Global Pathology Laboratory Operation Lead, the Clinical Pathology Laboratory Lead optimizes, incorporates and enables clinical pathology testing needs to support DSRD portfolio. Other responsibilities of the leader include ensuring the highest quality of raw data, contributing to methodology development for new biomarkers, contributing to technology development, and ensuring the Clinical Pathology laboratory maintains a continuous state of GLP inspection readiness. The Clinical Pathology Laboratory lead works across multiple laboratory groups to connect, align and eliminate any silos, and to work as a global unit. Clinical Pathology Laboratory lead serves as a mentor to Clinical Pathology Laboratory colleagues and provides leadership and opportunities to expand responsibilities for scientific growth and talent development.

ROLE RESPONSIBILITIES

The Clinical Pathology Lead is responsible for:
  • Performs all regulatory responsibilities in compliance with applicable regulatory standards and assures that the Clinical Pathology laboratory activities meet regulatory requirements such as GLP compliance, Pfizer policies, SOPs, Environmental Health and Safety
  • Serves as compliance officer for internal and external inspection audits. Responds to all audit findings to remediate areas of compliance risk; assures that global staff is adequately and appropriately trained, and that documentation of training is complete
  • Provides technical leadership in areas of expertise; Manages projects effectively; assigns roles to technical staff that allows personal development and meets the needs of the portfolio as well as responsible for staffing and recruitment
  • Provides GPM functions including interactive coaching and feedback sessions, development planning, individual and team goals, S1 and S2 assessments promotion reviews, compensation planning and reward and recognition programs.
  • Resolves areas of conflict, engages line management and HR support as needed.
  • Authors, reviews and approves a variety of reports such as: instrument and assay validation reports, budget assessments, project summaries, cross-site harmonization issues, meeting minutes and metrics reports
  • Monitors laboratory performance by partnering with operations lead by including assessment of metrics for efficiency, quality control and quality assurance programs for quality maintenance; Reviews study protocols, authors and/or signs Standard Operating Procedures; authors and/or signs instrument and assay validation protocols
  • Serves as a liaison for clinical and discovery projects as needed
  • Coordinates or assists in coordinating Clinical Pathology group meetings to provide effective communication from site leadership and provides educational presentations for larger staff meetings


QUALIFICATIONS
  • B.S. in Clinical Laboratory Science /Medical Technology with American Society for Clinical Pathology (ASCP) or other relevant certification
  • Prior management experience with training in leadership, supervisory, and management skills
  • Experience supervising high complexity laboratories consistent with guideline requirements
  • Ideally greater than 5 years of experience leading and managing a Clinical Pathology group within a pharmaceutical company, CRO, hospital or diagnostic company with technical expertise in a relevant field of Medical Technology or Clinical Pathology
  • Knowledge of Good Laboratory Practices (GLP)/ Good Clinical Laboratory Practices(GCLP), data collection systems, and data processing applications
  • Demonstration of excellent verbal and written communication skills, well organized, self-motivated, detail oriented, and has the ability to work and effectively communicate within a team environment


Organizational Relationships
  • Report to DSRD Global Pathology Laboratory Operation Lead
  • Key relationships within Global Pathology, Global Discovery Investigative and Translational Sciences, Global Toxicology, Regulatory Quality Assurance, CM and RUs


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • None


Other Job Details
  • Eligible for Relocation Package - YES


Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

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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