Company: CSL Limited
Posted on: February 24, 2021
Head, Toxicology United States of America R-128898 0606 Seqirus
Inc About CSL With operations in 35+ nations and -27,000 employees
worldwide, CSL is driven to develop and deliver a broad range of
lifesaving therapies to treat disorders such as hemophilia and
primary immune deficiencies, and vaccines to prevent influenza. Our
therapies are also used in cardiac surgery, organ transplantation
and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring
is a global leader in the protein biotherapeutics industry, focused
on bringing to market biotherapies used to treat serious and often
rare conditions. CSL Behring operates CSL Plasma, one of the
world's largest collectors of human plasma, which is used to create
CSL's therapies. Seqirus is one of the largest influenza vaccine
companies in the world and is a transcontinental partner in
pandemic preparedness and a major contributor to the prevention and
control of influenza globally.
We invite you to take a look at the many career possibilities
available around the globe and consider building your promising
future at CSL by becoming a member of our team! Job Description Job
Summary: The purpose of the position is to design, manage and
coordinate toxicology programs for Seqirus. Work will include
vendor selection, budgeting and monitoring of nonclinical safety
studies, as well as interpretation, communication and reporting of
the data generated. The incumbent will liaise closely with global
cross-functional project teams and interact with regulatory
authorities and external experts. The position will support the
development of new products as well as life cycle management. Major
- Develop toxicology strategies and provide toxicological expert
support to research and development projects.
- Plan, monitor, analyze and report nonclinical pharmacology and
toxicology studies conducted in collaboration with contract
- Serve as functional representative on global project
- Prepare nonclinical sections of regulatory submissions and
respond to information requests.
- Manage and prepare toxicological risk assessments to support
drug development and manufacturing. Evaluate data from extractable
and leachable studies. Support manufacturing as required for
changes in specifications, investigations into deviations and
- Participate in safety, quality, and project governance
- Create nonclinical sections for Investigator's Brochures, Risk
Management Plans, Product Information, Core Data Sheets, PSURs,
DSURs, and other documents.
- Maintain a high level of awareness of scientific developments
and the competitive environment to assist with strategic
re-evaluation of ongoing programs.
- Actively establish and foster a high quality, global network
with relevant experts internally and externally.
- DVM or PhD or advanced degree in relevant field. DABT
- 8-10+ years experience in relevant industry experience
- Knowledge and relevant toxicology experience in development of
biologics; Influenza and vaccines is preferred
- Knowledge and relevant experience with GxP regulations and
implementation, and GLP as applicable to conduct of nonclinical
- Knowledge and relevant experience with planning, monitoring,
and interpreting nonclinical studies.
- Ability to manage interactions with external suppliers, 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 protocols and reports for
- Ability to perform risk assessments. Share: State/Province
Massachusetts City Cambridge Primary Location Seqirus USA - MA -
Cambridge Full Time/Part Time Full Time Equal Opportunity Employer
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 click below.
Keywords: CSL Limited, Cambridge , Head, Toxicology
Minimum Requirements, Other , Cambridge, Massachusetts
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