Senior Manager, Toxicology Nonclinical Development

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

Teva’s Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies.

 

The nonclinical toxicologist will have a background in Biology or in a relevant field along with drug development experience in the pharmaceutical industry.  

 

You will be part of a skilled global department leading the scientific understanding of the safety of novel therapeutics (primarily biologics) in a company dedicated to finding therapies for various disease disorders.  You will be expected to execute and monitor nonclinical safety studies and interpret findings from these studies in support of clinical development.  

 

In addition, you must have an applied background in chemistry with knowledge in writing risk assessment documents in various nonclinical safety fields, including non-API impurities (eg. extractables/leachables), and knowledge of applicable regulations to support Teva’s pipeline. 

 

Furthermore, there may be need to provide safety assessment support to the development of generic products.  Your communication skills at all levels of interaction must be excellent, as you will work closely with colleagues within the organization.   

 

Additional Responsibilities:

• Develop a nonclinical safety plan to support clinical development and meet regulatory requirements.
• Design, monitor and coordinate the conduct of GLP and non-GLP toxicology studies at CROs in line with project timelines and budget.
• Understand the basic biology of the intended target of drug candidates and mechanisms of toxicity observed non-clinically and/or clinically in order to drive mitigation and/or back-up strategies to minimize potential harm to patients.
• Write nonclinical safety documents relating to the project, including nonclinical sections of regulatory submission documents, and participate in regulatory meetings.
• Write risk assessment documents for impurities (eg, extractables and leachables, degradation products, etc.). 
• Present data and interpretations in written and oral form to management and internal forums.
• Build collaborative networks to facilitate cross-functional communication and activities.

Qualifications

 

Required Qualifications:

• Master's degree in toxicology, biology or a related life-science field (eg Pharmacology/Pharmaceutics/Biochemistry, DVM, PharmD) 
• Minimum 4 years of toxicology experience in pharmaceutical/biotech/CRO setting performing drug development activities such as: designing and monitoring nonclinical studies, interpreting data, generating reports and regulatory documents 

 

Preferred Qualifications:

• PhD in Toxicology or related life science field of study
• Experience in nonclinical safety assessment throughout all stages of drug development, especially with biologics 
• Experience in scientific investigation of fundamental toxicology issues, either through scientific publications or drug development experience
• An accredited or registered toxicologist

Function

Sub Function

Reports To

Director, Nonclinical Safety Assessment

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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to  support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.