1+ months

Diagnostics Operations Lead

Cambridge, MA 02139
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+ 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.


+ Qualification of contract labs and Diagnostics partners for CDx assays.

+ 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).Manage to established timeframes and communicate progress to study teams, as appropriate.

+ In conjunction with internal groups (e.g. Precision Medicine and Translational groups), ensure that appropriate information on CDx sample collection/processing/handling is incorporated into lab manuals.

+ Responsible for assay validation reports (except when internal Pfizer groups have developed such assays), 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.

+ Periodically audit external CROs performing CDx assays that support Pfizer programs.

+ Maintain required paperwork from such audits in relevant Pfizer electronic databases.

+ Working with Procurement, coordinate critical orders required to keep CDx programs on track Contribute to the operational effectiveness of the Diagnostics Group.


+ Advanced science degree (e.g. MS, PhD, PharmD) and/or a degree in regulatory compliance/oversight related field.

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

+ In depth knowledge and experience in diagnostics, particularly companion diagnostics

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

+ Demonstrated excellent writing and communication skills.

+ In depth and hands-on experience in one or more technology platforms relevant to CDx assay development, such as immunohistochemistry, PCR, next generation sequencing, immunochemistry.

+ Extensive hands-on experience with compliance/oversight of diagnostics assays.

+ Experience in biomarker development or diagnostics industry preferred.

**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.

**Other Job Details:**

+ Eligible for Relocation Package: yes

+ Eligible for Employee Referral Bonus: yes


N (Other) (United States of America)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Posted: 2019-10-02 Expires: 2019-12-05

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Diagnostics Operations Lead

Cambridge, MA 02139

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