Senior Non - Clinical Toxicologist

CSL   •  

King Of Prussia, PA

Industry: Medical Devices & Diagnostics

  •  

5 - 7 years

Posted 244 days ago

Job Description

People who work for CSL Behring are committed to saving the lives of patients throughout the world. This involves top performance, as we strive to be the best. Join our team in the department Research, Pharmacology & Toxicology, Toxicology Unitas a

Senior Non-clinical Toxicologist (f/m)

Main Responsibilities and Accountabilities

  • Develop toxicology strategies and provide toxicological expert support to research and development projects.
  • Serve as function’s representative across activities in the area of antibody, plasma and recombinant protein development.
  • Manage and coordinate internal and external toxicology studies as part of global teams.
  • Support the preparation of national and international regulatory submissions.
  • Take responsibility as preclinical project lead for selected research or development projects.
  • Oversee and manage toxicology programs along clinical development up to marketing.
  • Plan, monitor, analyze and report preclinical pharmacology and toxicology studies conducted internally or in collaboration with external contract research organizations (CROs) for selected projects.
  • Manage and prepare toxicological risk assessments to support drug development and manufacturing.
  • Actively collaborate with global, cross-continental project teams.
  • Prepare and review non-clinical documents as part of regulatory submissions and interactions.
  • Support improvement initiatives to enhance efficiency and quality of the group's deliverables.

Qualifications / Experience / Competencies

  • Relevant Master’s degree in Life Sciences with in depth knowledge of Toxicology, PhD and board certification preferred
  • At least 5 years of experience as non-clinical toxicologist in a biotechnology, pharmaceutical or CRO setting.
  • Relevant experience in protein drug development.
  • In depth knowledge of relevant regulatory guidelines.
  • Strong scientific background in coagulation, immunology, intensive care medicine and/or protein sciences.
  • Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
  • Experience in working in cross-functional, multicultural and international teams.
  • Excellent communication and analytical skills.
  • Strong planning and organizational skills.
  • Ability to work successfully in a matrix organizational structure.
  • Strong negotiation skills and ability to identify and engage internal and external expertise as needed.
  • Fluent in English, oral and written; basic German or willingness to learn German.