Serves as a member of the clinical study team and bioanalytical subject matter expert for executing clinical study setup & conduct, contributing to the study protocol development & review, preparing submissions, addressing regulatory queries, implementing bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines.
Leads and oversees small or large molecule PK, PD, and immunogenicity (ADA and Nab) assay lifecycle management from early stage to registration encompassing executing analytical strategy, development and method design, validation, data quality review, corresponding sample analyses & reporting to meet evolving program objectives and regulatory expectations. Assists CROs with effective troubleshooting of the bioanalytical assay and issue resolution.
Functions as key point of contact with external & internal laboratories and supports (or leads, as appropriate) selection, qualification, performance evaluation, and periodic audits of CRO laboratories conducting clinical PK, PD and immunogenicity assays (as relevant to the role).
Supports the clinical trial conduct within scope of the Clinical Assay Group responsibilities, including development and review of documents and processes such as CRF and data setup, clinical site lab manual, sample management & reconciliation, bioanalytical study planning & reporting, budgeting & invoicing, compliance with clinical SOPs & policies, and regulatory inspection readiness & conduct.
Contributes to the development of Best Practices, processes, templates, and policies.
Maintains up-to-date knowledge of current and novel chromatographic separation/mass spectrometry based detection or ligand binding technologies & techniques (as relevant to the role), global regulatory guidances & expectations, and industry best practices.
As appropriate, additional responsibilities may include the following:
Leads development of novel complex methodologies, troubleshooting & resolution of complex technical & logistical issues with vendors and study teams. Identifies technology/capabilities gaps and proposes mitigation strategies, including development of novel technical capabilities with vendors. Scientifically evaluates complex data (i.e. evaluates aberrant results and data trends), anticipates and corrects potential issues, and able to appropriately guide study teams through complex issues resolution.
Leads internal and cross-functional organization initiatives, best practices and demonstrates internal and external influence.
Provides subject matter expertise, guidance and mentoring to colleagues. May have responsibility for dotted/direct line management of staff.
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place. Every day, our colleagues work in developed and emerging markets to ...