Biologics & Immunogenicity Clinical Assay Lead

Responsibilities

• Lead scientific and technical oversight of PK, PD, and immunogenicity (ADA and Nab) assay lifecycle management from early stage to registration
• Serve as a bioanalytical subject matter expert on clinical study teams to support protocol development, regulatory submissions, and query responses
• Oversee external and internal partners, including the selection, qualification, and performance evaluation of CRO laboratories
• Manage bioanalytical strategies, including method design, validation, data quality review, and sample analysis reporting
• Support clinical trial conduct through the development of lab manuals, sample management processes, and regulatory inspection readiness
• Troubleshoot complex technical and logistical issues with vendors and study teams

Requirements

• PhD in biology or analytical chemistry with 2-6 years of experience, MS with 3-6 years, or BS with 7-10 years of relevant industry experience
• 5-8 years of industry experience in PK or immunogenicity assay development, validation, and sample analysis
• Expertise in ligand binding methodologies, specifically ELISA and ECL
• Working knowledge of GxP regulations governing clinical trials and regulated bioanalysis
• Demonstrated ability to work in a highly matrixed environment and manage multiple projects simultaneously
• Strong verbal, written, and presentation communication skills

Preferred Qualifications

• Demonstrated experience in CRO management and outsourcing
• Experience with regulatory inspections and preparing regulatory submissions
• Hands-on experience with LC/MS quantitation of large molecules and immunocapturing hybrid assays
• Understanding of clinical trial design, pharmacokinetics, and clinical pharmacology
• Experience with biosimilars, gene therapy, or technologies such as RT-PCR, qPCR, and ELISPOT

Benefits

• Competitive annual base salary and eligibility for a performance-based bonus
• Comprehensive health benefits including medical, prescription drug, dental, and vision coverage
• 401(k) plan with Pfizer matching contributions and additional retirement savings contributions
• Paid vacation, holidays, personal days, and medical/parental leave

About the Company

Pfizer is a global leader in healthcare, dedicated to unearthing innovative therapies that transform millions of lives. We foster a culture of individual ownership and scientific excellence to make the world a healthier place.