Associate Director, Clinical Assay Strategy

CSL•Waltham, MA

1d•Hybrid

About The Position

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. Headquartered in Melbourne, Australia, with major manufacturing hubs in Holly Springs, NC, and Liverpool, UK, the company operates the world’s largest cell-based vaccine facility and serves as a primary partner to governments for global pandemic preparedness. Joining Seqirus now means being part of an agile team committed to developing vaccines that make a meaningful difference worldwide. Could you be our next Associate Director, Clinical Assay Strategy-Vaccines? The job is in our Waltham, MA Office. This is a hybrid position and is onsite three days a week. You will report to the Director, Clinical Assay Strategy. This role is intended for 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, and can strategically navigate assay modernization while maintaining regulatory alignment. You will provide scientific leadership and external oversight of vaccine serology and biomarker assays supporting clinical development programs. This is a strategic, non-laboratory-based role responsible for assay design, validation oversight, regulatory alignment, and vendor governance across global clinical programs.

Requirements

Bachelor's in Life Science.
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.

Nice To Haves

PhD preferred in Immunology, Virology, Microbiology, or related Life Sciences discipline preferred.

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.