Head, Toxicology
Job Summary:
Major Accountabilities:
Minimum Requirements

Company: CSL Limited
Location: Cambridge
Posted on: February 24, 2021

Job Description:

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 Accountabilities:

• 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 research organizations.
• Serve as functional representative on global project teams.
• 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 out-of-specification results.
• Participate in safety, quality, and project governance committees.
• 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 preferred.
• 8-10+ years experience in relevant industry experience required.
• 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 studies.
• 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 nonclinical studies.
• 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
Job Summary:
Major Accountabilities:
Minimum Requirements, Other , Cambridge, Massachusetts