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Head, Clinical Serology

Employer
CSL Behring
Location
Cambridge, Massachusetts
Start date
Nov 22, 2021

View more

Discipline
Clinical, Clinical Research
Required Education
Masters Degree/MBA
Position Type
Full time

Job Details

Job Description

Job Summary:

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.

Minimum Requirements:
  • 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

About Us

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

About Seqirus

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.

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

Do work that matters at Seqirus!

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Company info
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

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