Associate Director, Clinical Assay Strategy

CSL Seqirus is a global leader in influenza prevention and the world’s second‑largest influenza vaccine provider. Operating as a specialized division of CSL Limited, we are headquartered in Melbourne, Australia, with major manufacturing hubs in Holly Springs, NC, and Liverpool, UK. We operate the world’s largest cell‑based vaccine facility and serve as a primary partner to governments for global pandemic preparedness. We are looking for an Associate Director, Clinical Assay Strategy – Vaccines based in our Waltham, MA Office. This hybrid position requires on‑site presence three days a week and reports directly to the Director, Clinical Assay Strategy. Role Overview We seek a recognized subject matter expert who understands the scientific, operational, and regulatory evolution of influenza immunogenicity assessment, including HAI, microneutralization (MN), ELLA, and multiplex platforms. The successful candidate will provide scientific leadership and external oversight of vaccine serology and biomarker assays supporting clinical development programs. The role is strategic, non‑laboratory‐based, and responsible for assay design, validation oversight, regulatory alignment, and vendor governance across global clinical programs. Responsibilities Develop and execute clinical assay strategies for influenza vaccine programs across all phases of clinical development. Provide expert guidance on HAI assay design, optimization, regulatory expectations, and historical correlates of protection. Lead strategic implementation and interpretation of microneutralization (MN) assays. Oversee ELLA, Luminex‑based total IgG, subclass, and Fc‑effector analyses. Evaluate and guide adoption of multiplex platforms (e.g., Luminex) for expanded immune profiling. Lead assay bridging and concordance strategies during platform evolution or vendor transition. Assess context‑of‑use and regulatory acceptability of modernized assay platforms. Oversee assay qualification, validation, transfer, and lifecycle management aligned with FDA, EMA, ICH, and WHO guidance. Ensure validation parameters are appropriate for intended clinical endpoints (precision, accuracy, specificity, robustness). Provide strategic input for label‑enabling immunogenicity studies. Support regulatory submissions with validation documentation and responses to health authority queries. Anticipate regulatory risks associated with assay modernization in influenza programs. Lead technical evaluation and selection of external bioanalytical laboratories. Oversee assay transfers ensuring concordance, compliance, and data integrity. Establish vendor governance frameworks, KPIs, and performance oversight. Manage complex troubleshooting and scientific escalations with external partners. Ensure operational excellence across high‑throughput influenza clinical serology programs. Partner closely with Research, Clinical Development, Regulatory Affairs, Statistics, and CMC teams. Translate immunological data into strategic development decisions. Provide scientific leadership in a matrixed environment. Represent the organization at scientific conferences and regulatory forums. Qualifications & Experience Bachelor’s in Life Science; PhD preferred in Immunology, Virology, Microbiology, or a related Life Sciences discipline. 4+ years of industry experience in vaccine development. Significant experience in influenza vaccine serology strongly preferred. 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. The expected base salary range for this position at hiring is $179,000 – $212,000. Total compensation may also include incentive compensation and equity. Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit #J-18808-Ljbffr