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Irfa******
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Germany
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Last Update: 13.06.2019 at 03:42
Job Type
Full Time
Start
Jun , 2019
Duration
6 Month
Place
Biberach
Country
Germany
Category
General Administrative
Description
Tasks and responsibilitiesYou act as Team Leader Rodent Toxicology with 5 direct scientific reports and direct a reproductive toxicology laboratory.As Study Director in nonclinical in vivo safety studies (non GLP and GLP) you focus on developmental and reproductive toxicology (DART) studies as well as rodent toxicology studies.You provide nonclinical safety expertise in drug development teams and participate in compilation of regulatory documents (e. g. IB, IND, DSUR) and safety assessments.A special area of your toxicological expertise will be DART and the regulatory guidance connected to this field, where you support development teams on DART topics.You contribute to developing our laboratory in vivo methods in the spirit of the 3R’s.Furthermore, you optimize our GLP environment, serve as contact person for our Quality Assurance Unit and prepare the group for internal and authority GLP inspections.If adequately qualified, you will participate in the safety evaluation of in licensing candidates.RequirementsDoctoral Degree in Toxicology, Pharmacology, Veterinary Medicine, Biology or a related fieldSeveral years of toxicological in vivo experience and as a Study Director for nonclinical safety studies under GLP, preferably in the pharmaceutical area or in a CROGood understanding of regulatory guidance for nonclinical development of active pharmaceutical ingredientsBoard Certification in toxicology (ERT, DABT) is a plus. Willingness to prepare for board certification is expectedExceptional written and verbal communication skills in English as well as good communication skills in GermanAdept management skillsGood team working abilities, a high degree of self motivation and a proactive approach to work