Biologics & Immunogenicity Clinical Assay Lead

Role Summary

Biologics & Immunogenicity Clinical Assay Lead, within Clinical Bioanalytics, supports clinical strategies across all stages of drug development and post-marketing activities. Provides scientific and technical leadership, oversight, and management of internal and external partners to deliver quality, timely, and regulatory compliant PK, PD, and immunogenicity bioanalytical assays and data.

Responsibilities

• Serves as a member of the clinical study team and bioanalytical subject matter expert for executing clinical study setup and conduct, contributing to 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, 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 and reporting to meet evolving program objectives and regulatory expectations. Assists CROs with troubleshooting of the bioanalytical assay and issue resolution.
• Functions as key point of contact with external and internal laboratories and supports (or leads, as appropriate) selection, qualification, performance evaluation, and periodic visits and audits of CRO laboratories conducting clinical PK, PD 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.
• As appropriate, additional responsibilities may include: leads development of novel complex methodologies, troubleshooting and resolution of complex technical and logistical issues with vendors and study teams; identifies technology gaps and proposes mitigation strategies; scientifically evaluates complex data and guides study teams through issue resolution; leads internal and cross-functional initiatives; provides SME guidance and mentoring to colleagues, with potential dotted/direct line management of staff.

Qualifications

Must Have

• PhD or equivalent in biology or analytical chemistry/chemistry with 2 to 6 years of experience
• M.S with 3 to 6 or B.S. with 7 to 10 years of relevant industry experience
• Minimum of 5-8 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 guidance and expectations relevant to regulated bioanalysis
• Subject matter expert in regulated bioanalysis of biologics and understanding of bioanalytical techniques commonly used for biomarkers
• In-depth knowledge of GxP regulations governing conduct of clinical trials and regulatory guidance and expectations relevant to regulated bioanalysis
• Demonstrated ability to think strategically, work in a highly matrixed environment, and execute multiple projects simultaneously
• Highly effective communication skills: verbal, written, and presentation

Nice to Have

• Demonstrated CRO management and outsourcing experience
• Experience with regulatory inspections
• Experience preparing regulatory submissions and addressing regulatory queries
• 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)
• Prior experience with training, mentoring, or managing colleagues
• Hands-on experience with the development, validation and troubleshooting of methods for PK and immunogenicity (including determining assay cut points, tolerance, and sensitivity) and implementing ACE, BEAD, and SPEAD methodologies
• Hands-on experience with the development, validation, and troubleshooting of LC/MS quantitation of large molecules and immunocapturing hybrid assays
• Understanding of critical reagent generation and 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