CDI Research Toxicologist H/F Bayer

Détail du poste

Responsible for development, implementation and application of new approach methods (NAMs) either internally or in collaboration with external parties to : Provide support and guidance during the development and optimization of new candidate molecules in collaboration with pipeline product responsible toxicologists Support for later phase molecules to strengthen the chances of regulatory success and continued licence to operate. Contribute to the regulatory acceptance of NAMs and NGRA in collaboration with regulatory toxicologists, PK and modelling experts Local Key Tasks :
- BE responsible, within area of expertise, for assigned projects and/or toxicological endpoints (e.g. completeness and quality of data, set up of new study designs and/or new biomarkers) - Ensure that all studies, method validation and/or tools required for implementation of NAMs or mode of action elucidation are initiated on time and meet the demands of good data quality management, as well as fulfil all safety aspects - Provide planning, scheduling and cost estimates to pipeline product responsible and regulatory toxicologists - Participate in or lead, with appropriate support, interdisciplinary projects (Product or Technical Teams) and BE fully accountable for the area of expertise within the project - Present data in internal working groups or, with appropriate support, to external working groups and/or regulatory authorities - Maintain a sound awareness of international regulatory testing guidelines, requirements and criteria and follow new developments, policies and global trends - Develop strategies and work programs in area of expertise to successfully address current and/or new regulatory requests - Develop understanding of regional and global impact of assigned projects and activities - Collaborate with external consultants, academia and/or CROs - Training / mentoring of new colleagues (e.g. Post Docs) High level of education (PhD / Doctorate) in Toxicology or a closely related science (DVM, PharmD, Biologist, Biochemist,). 3 to 5 years of experience in the field Ability to manage research projects. Knowledge of international regulatory guidelines and GLP principles. Ability to conduct scientific project using animal (Directive 2010/63/EU) : Level 1/B. Ability to work both independently and as part of a multidisciplinary team Capable of conveying scientific and technical information in a clear and thorough manner Strong oral and written communication skills Excellent interpersonal, teamwork, and organizational skills Fluent in English, both written and spoken, French would BE an advantage