ROLE SUMMARY

As a member of the Clinical Bioanalytics (CBx) group within Transitional Clinical Sciences, Clinical Assay Lead will play a critical role in supporting clinical strategies in all stages of drug development and post marketing activities by providing scientific and operational oversight to internal/external stakeholders and delivering quality, timely, and regulatory compliant PK, PD bioanalytical assays, data and reports.

ROLE RESPONSIBILITIES

• 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 molecule PK, PD assay lifecycle management from early stage to registration encompassing analytical 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 selection, qualification, performance evaluation, and periodic audits of CRO laboratories conducting clinical PK assays.
• 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 technologies & techniques, global regulatory guidances & expectations, and industry best practices

• Bachelors with a minimum of 10 years or Masters or Ph. D degree with a minimum of 5 years bioanalytical experience in Pharma or CRO specializing in PK assay development, validation, and sample analyses using chromatographic/mass spectrometry methodologies.
• Working knowledge of GxP regulations governing conduct of clinical trials and regulatory guidances and expectations relevant to regulated bioanalysis.
• Demonstrated ability to think strategically, work in a highly matrixed environment, and execute multiple projects simultaneously.
• Highly effective verbal and written communication and presentation skills.