Head, Clinical Serology
The purpose of the position is to manage a group dedicated to analytical support of clinical trials. Work will include virological and immunological testing. The position will support the Clinical Development department with expertise regarding existing and novel assays for the assessment of vaccine immunogenicity and efficacy with GxP knowledge. Will support testing laboratories with critical reagent qualification, assay validation and QA/QC expertise. Will collaborate with Research department for development and deployment of novel assays and troubleshooting of current clinical testing. Will provide analytical expertise support in interactions with regulatory agencies, when required.Major Accountabilities:
Provides a clinical assay strategy based on technical expertise and critical reviews of clinical testing laboratories with regard to critical reagents selection and qualification, assay qualification and validation and QA/QC of clinical specimen testing. It will support and monitor testing laboratories in selecting, procuring and characterizing critical reagents, planning and performing assay qualification and validation, and performing testing of clinical specimens according with required GxP regulations.
Provide technical expertise and critical input to the Clinical Development department for selection of appropriate established analytical endpoints and for development and deployment of new analytical parameters. It will participate in the draft of clinical protocols by providing expert information on availability and validity of analytical endpoints. It will contribute to the statistical plan and analysis by providing relevant information on assay performance.
Maintain updated knowledge of the analytical field related to current and novel vaccine candidates, to allow for the most appropriate and informative analysis of clinical samples. It will provide analytical input and expertise in any interaction with regulatory agencies.
Interact with the research group for the development of novel analytical assays and with their deployment and assessment in clinical setting. It will assure that novel preclinical testing will be developed that can progress to clinical use and support application in a regulated environment.
Interact with regulatory bodies and vendors to assure Seqirus is compliant and the endpoints for clinical trials are supported with properly performed clinical assays.
PhD or advanced degree in relevant immunology and biology fields
5-10+ years experience. Prior industry experience required.
Knowledge and relevant laboratory experience in the fields of immunology, virology, and cell biology.
Knowledge and understanding of Influenza virus and vaccines is strongly preferred
Knowledge and relevant experience with GxP regulations and implementation, as they apply to analytical testing in support of clinical trials.
Knowledge and relevant experience with assay qualification and validation.
Ability to multitask and to work on multiple research projects in parallel
Ability to manage interactions with external laboratories, and provide meaningful supervision of work sponsored by Seqirus and performed outside Seqirus
Good demonstration of time and resource management, communication, and teamwork
Ability to generate written reports or publications, to prepare and present data at cross-functional meetings and to internal and external stakeholders, and to demonstrate ownership, understanding, and accountability of assigned projects.
Ability to critically review reports and compliance documentation as they apply to analytical testing
Demonstration of intellectual and scientific curiosity, a high level of engagement and personal initiative.
Familiarity with biosafety
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Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.
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