1+ months

Diagnostics Operations Lead

Pfizer
Boulder, CO 80302
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**ROLE SUMMARY**



+ Provide vendor oversight support to Companion Diagnostics (CDx) programs across the R&D Organization, from Research to Development and Commercialization.

+ Oversight of CDx assay programs contracted to Clinical Laboratories/Contract Research Organizations (CROs) to ensure they meet all regulatory requirements.



Provide Operational support to CDx programs, Diagnostics Group members and members of other Pfizer groups collaborating on CDx development and delivery.



**ROLE RESPONSIBILITIES**



+ Qualification and periodic audit of external contract labs for CDx assays. Maintain associated documentation in relevant Pfizer electronic databases.

+ Provide direction to and oversight of CDx assay work performed at external CROs.

+ Assist in the transfer of diagnostics assays developed internally at Pfizer to external CROs or Diagnostics companies.

+ Coordinate operational aspects of CDx implementation in clinical trials (all phases) including sample and data management activities with external vendors. Manage to established timeframes and communicate progress to study teams, as appropriate.

+ Incorporate appropriate information on CDx sample collection/processing/handling into lab manuals.

+ May be responsible for assay validation reports where appropriate, to ensure laboratories are performing analysis in compliance with appropriate regulatory and industry standards.

+ Stay abreast of literature, government guidelines, and internal guidance on clinical trial conduct including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), GCLP, CAP and CLIA.

+ Maintain and abide by internal SOPs and regulations, as appropriate, for diagnostics assay development and testing.

+ Coordinate critical work orders required to keep CDx programs on track



Contribute to the operational effectiveness of the Diagnostics Group.



**QUALIFICATIONS**



**"Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve** **meaningful outcomes and create business impact."**



+ Advanced science degree (e.g. MS, PhD, PharmD) and/or B.S. with experience in GCP/Regulatory environment.

+ Demonstrated understanding of regulatory requirements and application of quality systems (GLP, GCP, GCLP, CLIA, CAP).

+ Experience in diagnostics, particularly companion diagnostics

+ 3+ years of relevant regulatory compliance/oversight experience in a setting relevant to drug development and/or CDx development.

+ Demonstrated excellent writing and communication skills.

+ Familiarity with one or more technology platforms relevant to CDx assay development, such as immunohistochemistry, PCR, next generation sequencing, immunochemistry.



Experience in Oncology biomarker development preferred.



\#LI-PFE



**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.



Continuous Imprv and Proj Mgmt
Posted: 2020-02-07 Expires: 2020-04-09

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Diagnostics Operations Lead

Pfizer
Boulder, CO 80302

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