For our Pharmacology & Toxicology department we are looking for a Senior Toxicologist (f / m) (full-time / permanent) Position Purpose As Senior toxicologist, this role is responsible for developing the toxicology strategy of assigned programs.
The incumbent will be responsible for the design, adequate budgeting and monitoring of non-clinical safety studies conducted internally and externally both in a GLP and non-
GLP environment. 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 protein drug and gene therapy 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 the preclinical evaluation of external assets and in-
licensing opportunities Oversee a global team of functional experts and assigned budget Support improvement initiatives to enhance efficiency and quality of the group's deliverables.
Maintain a high level of awareness of scientific developments and the competitive environment to assist on ongoing strategic re-
evaluation of ongoing programs. Actively establish and foster a high quality, global network with relevant experts internally and externally Qualifications / experience Advanced degree (PhD, MD, PharmD) in Life Sciences or closely related fields Toxicology training, board certification preferred.
At least 10 years of experience as non-clinical toxicologist in a biotechnology, pharmaceutical or CRO setting. Relevant experience in protein drug development.
Additional experience in development of gene therapies, 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.
Good understanding of drug development process, strong knowledge of ICH / GLP 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 If you are interested in this challenging position, please apply via our website.
Marburg, 23.08.2018 CSL Behring GmbH Human Resources Position number : R-074497 Worker Type : Employee Worker Sub Type : Regular