CSL
Associate Director, Clinical Assay Strategy, Flu
Seqirus USA - MA - Waltham · Director
Sponsorship not specified$179k-$212kDetected 21 days ago
StatisticsFDA RegulatoryResearchProtein AnalysisLeadershipCollaborationRegulatory Affairs
About the role
- 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.
- Could you be our next Associate Director, Clinical Assay Strategy-Flu?
- This is a hybrid position and is onsite three days a week.
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.
- Lead assay bridging and concordance strategies during platform evolution or vendor transition.
- Lead technical evaluation and selection of external bioanalytical laboratories.
- Manage complex troubleshooting and scientific escalations with external partners.
- Partner closely with Research, Clinical Development, Regulatory Affairs, Statistics, and CMC teams.
Requirements
- Bachelor's in Life Science.
- Experience in influenza vaccine required
Compensation
- The expected base salary range for this position at hiring is $179,000 - $212,000.
Benefits
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
- Support regulatory submissions with validation documentation and responses to health authority queries.
Company info
- At CSL, Inclusion and Belonging is at the core of our mission and who we are.
Equal opportunity
- 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 https://www.csl.com/accessibility-statement.
- Watch our 'On the Front Line' video to learn more about CSL Seqirus
This listing is sourced directly from CSL's careers page and normalized into a canonical job model.