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.

• 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.

• 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.

Base salary range: $179,000 – $212,000, with additional incentive compensation and equity opportunities. Compensation will be based on qualifications, experience and other factors.

CSL is an Equal Opportunity Employer. If you need a reasonable accommodation for any part of the application process, please contact us.