Role Summary
As a Clinical Assay Lead within the Clinical Bioanalytics (CBx) group in Transitional Clinical Sciences, you will be instrumental in supporting clinical strategies throughout drug development and post-marketing activities. You will provide scientific and operational oversight to both internal and external stakeholders, ensuring the delivery of high-quality, timely, and regulatory-compliant PK and PD bioanalytical assays, data, and reports.
Role Responsibilities
Study Support: Act as a bioanalytical subject matter expert within the clinical study team, contributing to protocol development and review, preparing submissions, addressing regulatory queries, and implementing bioanalytical strategies and assays. Ensure regulatory compliance and timely delivery of data and reports.
Assay Management: Lead and manage the lifecycle of small molecule PK and PD assays from early development through registration. This includes analytical development, method design, validation, data quality review, sample analysis, and reporting, in line with program objectives and regulatory expectations. Assist CROs in troubleshooting bioanalytical assays and resolving issues.
Laboratory Oversight: Serve as the primary contact for external and internal laboratories. Support the selection, qualification, performance evaluation, and periodic auditing of CRO laboratories conducting clinical PK assays.
Clinical Trial Conduct: Support clinical trial activities within the Clinical Assay Group's scope, including document and process development (e.g., CRF, clinical site lab manual), sample management and reconciliation, bioanalytical study planning and reporting, budgeting and invoicing, compliance with SOPs and policies, and regulatory inspection readiness.
Process Improvement: Contribute to the development of best practices, processes, templates, and policies. Maintain current knowledge of chromatographic separation and mass spectrometry techniques, global regulatory guidance, and industry best practices.
Basic Qualifications
Work Location
This position is remote.
Equal Opportunity Employer
Pfizer is an equal opportunity employer and adheres to all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
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Goa | Panaji |Gujarat :
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Punjab :
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Minneapolis and St. Paul, Minnesota. |Missouri :
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Zagreb |Republic of Egypt :
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Seoul |Capital of Netherland :
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Switzerland | Remote, USA | Remote - Europe | Remote |Makkah :
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Barcelona |Republic of Thailand :
Bangkok |