Associate Director, Clinical Assay Strategy, Flu

Overview CSL Seqirus is a global leader in influenza prevention and the world’s second‑largest influenza vaccine provider. This role is the Associate Director for Clinical Assay Strategy – Flu, based in Waltham, MA, and is hybrid (onsite three days a week) reporting to the Director of Clinical Assay Strategy. Responsibilities Provide scientific leadership and external oversight of vaccine serology and biomarker assays supporting clinical development programs. Design, validate, and standardize influenza immunogenicity assays, including HAI, microneutralization (MN), ELLA, and multiplex platforms (e.g., Luminex). Lead strategic implementation and interpretation of MN assays and oversee ELLA, Luminex‑based total IgG, subclass, and Fc‑effector analyses. Guide adoption of multiplex platforms for expanded immune profiling and manage assay bridging and concordance during platform evolution or vendor transition. Assess context‑of‑use and regulatory acceptability of modernized assay platforms and anticipate regulatory risks. Oversee assay qualification, validation, transfer, and lifecycle management aligned with FDA, EMA, ICH, and WHO guidance. Support regulatory submissions with validation documentation and responses to health authority queries. Lead technical evaluation, selection, and governance of external bioanalytical laboratories and vendors, ensuring performance and data integrity. Collaborate cross‑functionally with Research, Clinical Development, Regulatory Affairs, Statistics, and CMC teams to translate immunological data into strategic decisions. Represent CSL Seqirus at scientific conferences and regulatory forums. Qualifications & Experience Bachelor’s degree in Life Science; PhD preferred in Immunology, Virology, Microbiology, or related discipline. 4+ years of industry experience in vaccine development, with experience in influenza vaccine required. Demonstrated expertise in HAI and MN assay validation and regulatory positioning. Experience in ELISA and multiplex immune assay development. Experience supporting regulatory submissions involving vaccine immunogenicity endpoints. Proven experience managing outsourced clinical bioanalytical programs. Salary Base salary range: $179,000 – $212,000, with additional incentive compensation and equity opportunities. Compensation will be based on qualifications, experience and other factors. Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you need a reasonable accommodation for any part of the application process, please contact us. #J-18808-Ljbffr