Manager, Clinical Diagnostics Operations
Pfizer Inc.
Washington – Bothell, NY
Job posting number: #7285268 (Ref:pf-4922003)
Posted: October 1, 2024
Job Description
ROLE SUMMARY:
The Manager of Clinical Diagnostics Operations will oversee clinical diagnostic operations in support of late and early-stage clinical oncology development programs. The primary role of this position will include streamlining and standardizing clinical diagnostic operations and developing and operationalizing clinical trial assays through close collaboration with partner companies as well as members of the Translational Operations and Clinical Development functions. This position has the option of being based remotely or in either of our Bothell, Seattle, or South San Francisco offices.
ROLE RESPONSIBILITIES:
Streamline and standardize clinical diagnostic operations within the scope of the Companion Diagnostic function.
Support vendor interactions, audits and contracting.
Manage clinical trial assay result workflows
Author and review trial protocols, ICF’s and assay sections of regulatory documents
Key member of clinical study teams to support proper collection of specimens.
Work with internal and external partners to develop analytically validated clinical trial assays
QUALIFICATIONS:
Candidates must have a Ph.D with relevant industry experience.
Expertise in clinical trial operations, with a focus on biomarker testing and reporting.
Expertise in assay methodologies such as in situ hybridization, immunohistochemistry, PCR and NGS.
Experience with assay transfers and validation.
Experience communicating development plans, issues, and risks in written and verbal format.
Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
Excellent communication, analytical and organizational skills.
Work Location Assignment:Hybrid
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
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.
