Senior Toxicologist, Advanced Therapeutic Medicinal Product (ATMP)

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Jun 28, 2022
Ref
R-173842
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Contract
Job Description

Senior Toxicologist, Advanced Therapeutic Medicinal Product (ATMP)

Responsibilities:

  • Develop non-clinical development strategies and provide scientific expertise to research and development projects.

  • Serve as function’s representative across gene therapy/ATMP projects and act as preclinical project lead for selected gene therapy projects

  • Plan, monitor, analyze and report preclinical pharmacology and toxicology studies conducted internally or in collaboration with external contract research organizations (CROs) for selected projects.

  • Oversee and manage non-clinical development activities to support, process development, clinical development, marketing and manufacturing of gene therapy products.

  • Prepare and review non-clinical documents as part of regulatory submissions and interactions and interact with health authorities as required.

  • Manage and prepare toxicological risk assessments to support drug development and manufacturing.

  • Maintain a high level of awareness of scientific and regulatory developments and the competitive environment to assist on ongoing strategic re-evaluation of ongoing programs.

  • Actively collaborate with global, cross-continental project teams.

  • Actively contribute to and foster a high quality, global network with gene therapy/ATMP experts internally and externally

  • Support improvement initiatives to enhance efficiency and quality of the group's deliverables.

Education

  • Advanced degree (PhD and PharmD) in Life Sciences OR Veterinary Doctor (VetD) or closely related fields required

  • Toxicology training

Experience

  • At least 5+ years of experience as non-clinical scientist in a biotechnology, pharmaceutical or CRO setting.

  • In depth knowledge of molecular biology, stem cell biology, in vivo/ex vivo gene therapy and gene editing

  • Relevant experience in gene therapy development

  • Additional experience in development of biologics (protein, mABs, RNA based therapies) and/or small molecules of advantage

  • In depth knowledge of relevant regulatory guidelines.

  • Strong scientific background in at least one of the following therapeutic areas: hematology, immunology, transplantation, cardiovascular disease, pulmonology

Competencies

  • 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. Experience in medical/regulatory writing preferable.

  • Experience in analyzing and presenting research results to scientific and professional audiences.

  • 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.

  • Good understanding of drug development process, strong knowledge of ICH/GLP

  • Fluent in English, oral and written required.

  • Ability to communicate in or willingness to learn Germ preferred.

Working Conditions

  • Working across global time zones ie., US, Germany, Australia etc.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms

Travel Requirements

About Us

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL 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 CSL.

Do work that matters at CSL Behring!