Biologics & Immunogenicity Clinical Assay Manager

Role Summary

As a member of Clinical Bioanalytics within Translational Clinical Sciences, the Biologics and Immunogenicity Clinical Assay Lead supports clinical strategies across all stages of drug development and post-marketing activities. The role provides scientific and technical support, oversight and management of internal and external partners to deliver quality, timely, and regulatory compliant PK and immunogenicity bioanalytical assays and data. Location: On Premise.

Responsibilities

• Serves as a member of the clinical study team and bioanalytical subject matter expert for executing clinical study setup and conduct, contributing to the study protocol development and review, preparing submissions, addressing regulatory queries, implementing bioanalytical strategies and 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 from early stage to registration, encompassing executing analytical strategy, development and method design, validation, data quality review, corresponding sample analyses and 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 and internal laboratories and supports selection, qualification, performance evaluation, and periodic visits and audits of CRO laboratories conducting clinical PK and immunogenicity assays.
• Supports the clinical trial conduct within scope of the Clinical BioAnalytics responsibilities, including development and review of documents and processes such as CRF and data setup, clinical site lab manual, sample management and reconciliation, bioanalytical study planning and reporting, budgeting and invoicing, compliance with clinical SOPs and policies, and regulatory inspection readiness and conduct.
• Contributes to the development of Best Practices, processes, templates, and policies.
• Maintains up-to-date knowledge of current and novel ligand binding technologies and techniques, global regulatory guidance and expectations, and industry best practices.

Qualifications

• Required: PhD or equivalent in biology or analytical chemistry/chemistry with < 2 years of experience.
• Required: B.S. with 5 to 6 years of relevant industry experience OR M.S with 3 to 5 years of relevant experience.
• Required: 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.
• Required: Working knowledge of GxP regulations governing conduct of clinical trials and regulatory guidance and expectations relevant to regulated bioanalysis.
• Required: In-depth knowledge in regulated bioanalysis of Biologics and Immunogenicity.
• Required: Demonstrated ability to think strategically, work in a highly matrixed environment, and execute multiple projects simultaneously.
• Required: Highly effective communication skills: verbal, written, and presentation.
• Preferred: Demonstrated CRO management and outsourcing experience.
• Preferred: Experience with regulatory inspections.
• Preferred: Experience preparing regulatory submissions and addressing regulatory queries.
• Preferred: Understanding of clinical trial design and overall principles of clinical development and related disciplines (e.g., pharmacokinetics and clinical pharmacology, statistics, ADME, formulation and drug product).
• Preferred: Prior experience with training, mentoring, or managing colleagues.
• Preferred: Hands-on experience with the development, validation and troubleshooting of methods for PK and immunogenicity (including the determination of assay cut points, tolerance, and sensitivity) and clinical sample analysis.
• Preferred: Hands-on experience with the development, validation, and troubleshooting of LC/MS quantitation of large molecules and immunocapturing hybrid assays.
• Preferred: Understanding of critical reagent generation and lifecycle management.

Skills

• Strategic thinking and ability to work in a highly matrixed environment, and to manage multiple projects simultaneously.
• Excellent verbal, written, and presentation communication skills.
• Demonstrated CRO management and outsourcing experience.
• Experience with regulatory inspections and regulatory submissions.
• Understanding of clinical trial design and related disciplines (pharmacokinetics, clinical pharmacology, statistics, ADME, formulation and drug product).
• Hands-on experience with PK and immunogenicity method development, validation, troubleshooting, and clinical sample analysis (including assay cut points, tolerance, and sensitivity) and experience implementing ACE, BEAD, and SPEAD methodologies.
• Hands-on experience with LC/MS quantitation of large molecules and immunocapturing hybrid assays.
• Knowledge of ligand binding technologies and bioanalytical assay development.