As a member of the Clinical Assay Group within Global Clinical Pharmacology, the successful candidate will play a critical role in supporting clinical strategies in all stages of drug development and post marketing activities through scientific and technical oversight and management of external and internal partners involved in delivering quality, timely, and regulatory compliant large molecule PK, PD, and immunogenicity analytical assays and data.
- 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 large molecule PK and immunogenicity (ADA and Nab) assay lifecycle management encompassing executing analytical strategy, development, 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, PD, and Immunogenicity 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 ligand binding technologies & techniques, global regulatory guidances & expectations, and industry best practices
PhD or equivalent in biology or analytical chemistry/chemistry. M.S. and B.S. degrees will be considered based on relevant industry experience
- Minimum of 5 years of industry or bioanalytical experience with PK and/or immunogenicity assay development, validation, and sample analyses using ligand binding (ELISA and ECL) 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 skills.
- Hands-on experience with the development, validation and troubleshooting of the methods for PK and immunogenicity (including the determination of assay cut points, tolerance, and sensitivity along with experience implementing ACE, BEAD, and SPEAD methodologies) and clinical sample analylsis.
- Understanding of critical reagent generation & lifecycle management
- Experience with biosimilars, gene therapy, multi-domain therapeutics, immunocapture, protein binding, cell based assays and technologies such as RT-PCR, qPCR, ELISPOT, AMS and FACs.
- Demonstrated CRO management and outsourcing experience.
- Experience with regulatory inspections.
- Experience preparing regulatory submissions and addressing regulatory queries.
- Basic understanding of clinical trial design and overall principles of clinical development and related disciplines (e.g., pharmacokinetics and clinical pharmacology, statistics, immunology, human ADME, formulation and drug product).