Safety Science Lead
In this position you will serve as Safety Science Lead (SSL) or CPS Lead for the therapeutic area CRM (Cardio Renal Metabolic diseases). Your role covers the nonclinical testing strategy, toxicological assessments and the preparation of regulatory documents.
This position has a hybrid setup with approximately 2-3 days per week on site.
Tasks & responsibilities
In your new role, you will serve as the Safety Science Lead or CPS Lead within Clinical Pharmacology and Non-Clinical Safety Sciences (CPS) forthe therapeutic area CRM (CardioRenalMetabolic diseases)
You will support the implementation of scientifically robust non-clinical safety project strategies, spanning from NTC discovery through clinical trial execution to regulatory submission across various modalities, ensuring alignment with external requirements and benchmark project strategies.
Furthermore, you will plan, conduct, and oversee nonclinical safety development programs for multiple assets in parallel, focusing on new entities in CRM.
In addition, you will generate concise nonclinical safety assessments to support internal decision-making and prepare regulatory submission documentation, facilitating health authority reviews and approval processes throughout all phases of pre-clinical and clinical drug development.These assessments include the toxicological qualification of impurities.
Requirements
PhD or equivalent degree in Human Medicine, Veterinary Medicine, Biochemistry, Biology, or comparable training/education
Several years of experience in regulatory nonclinical drug safety for human pharmaceuticals. This includes experience as expert author of regulatory documents such as IB or CTDs
Ability to handle complexity in drug development and the management of interfaces
Training in toxicology (board certificate) or pathology (board certificate) or comparable experience would be of high advantage
Fluency in English, both spoken and written
Applications from persons with severe disabilities are warmly welcomed. In cases of equal qualifications, such applicants will be given preferential consideration in the selection process.
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