Biologics & Immunogenicity Clinical Assay Lead

Biologics & Immunogenicity Clinical Assay Lead

• United States - Massachusetts - Cambridge

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life‑changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

As a member of Clinical Bioanalytics within Translational Clinical Sciences, the Biologics & Immunogenicity Clinical Assay Lead will play a critical role in supporting clinical strategies in all stages of drug development and post‑marketing activities through scientific and technical leadership, oversight and management of external and internal partners involved in delivering quality, timely, and regulatory compliant PK, PD, and/or immunogenicity bioanalytical assays and data.

Reports to Biologics and Immunogenicity Group Lead or Small Molecule Clinical Assay Lead with supervisor responsibilities, Clinical Bioanalytics, within Translational Clinical Sciences.

Frequent interaction with colleagues in Translational Clinical Sciences, Clinical, Medicines or Biomedicines Design (PDM/BMD), Clinical Operations, Data Management, Statistics, Regulatory, and Finance, as appropriate.

Frequent interaction with bioanalytical Contract Research Organizations (CROs), Central Laboratories, and, as appropriate, external collaborators.

Member of Clinical sub‑teams and study teams.

• Serve as a member of the clinical study team and bioanalytical subject‑matter expert for executing clinical study setup & conduct, contributing to protocol development & review, preparing submissions, addressing regulatory queries, implementing bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines.
• Lead and oversee large molecule PK, PD, and immunogenicity (ADA and Nab) assay lifecycle management from early stage to registration encompassing analytical strategy, development and method design, validation, data quality review, sample analyses & reporting to meet evolving program objectives and regulatory expectations. Assist CROs with effective troubleshooting of the bioanalytical assay and issue resolution.
• Function as key point of contact with external & internal laboratories and support (or lead, as appropriate) selection, qualification, performance evaluation, and periodic visits and audits of CRO laboratories conducting clinical PK, PD and immunogenicity assays.
• Support 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 & reconciliation, bioanalytical study planning & reporting, budgeting & invoicing, compliance with clinical SOPs & policies, and regulatory inspection readiness & conduct.
• Contribute to the development of best practices, processes, templates, and policies.
• Maintain up‑to‑date knowledge of current and novel ligand binding technologies & techniques, global regulatory guidance & expectations, and industry best practices.
• Lead development of novel complex methodologies, troubleshooting & resolution of complex technical & logistical issues with vendors and study teams. Identify technology/capability gaps and propose mitigation strategies, including development of novel technical capabilities with vendors. Scientifically evaluate complex data, anticipate and correct potential issues, and guide study teams through complex issue resolution.
• Lead internal and cross‑functional organization initiatives, best practices and demonstrate internal and external influence.
• Provide subject‑matter expertise, guidance and mentoring to colleagues. May…