Pfizer
Manager, Clinical Diagnostics Operations
Pfizer, Bothell, Washington, United States, 98021
Manager, Clinical Diagnostics Operations
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, ICFs, 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:
HybridThe annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share-based long-term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental, and vision coverage.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.
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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, ICFs, 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:
HybridThe annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share-based long-term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental, and vision coverage.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.
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