Manager, Biologics Clinical Assay Lead
The Clinical Assay Lead plays a critical role in delivering quality and compliant PK, PD, and immunogenicity bioanalytical assays and data through all stages of clinical biotherapeutic drug development and applicable post marketing activities. This is achieved through scientific and technical leadership, external and internal laboratory partnerships, clinical trial execution, and submission support.
- 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 with 3+ years of industry or bioanalytical experience with PK and/or immunogenicity assay development, validation, and sample analyses using ligand binding (ELISA and ECL) methodologies, Master's degree with 5+ years OR Bachelor's degree with 7+years.
- 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 analysis.
- 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).
- 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 preparing regulatory inspections, submissions and addressing regulatory queries.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Work Location Assignment:Flexible
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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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.Medical