Safety Science Lead

Stellenbeschreibung:

Position

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 set up with approximately 2–3 days per week on site.

Tasks & Responsibilities

Serve as the Safety Science Lead or CPS Lead within Clinical Pharmacology and Non-Clinical Safety Sciences for the therapeutic area CRM (CardioRenalMetabolic diseases).
Support 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.
Plan, conduct, and oversee nonclinical safety development programs for multiple assets in parallel, focusing on new entities in CRM.
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 preclinical 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, including experience as expert author of regulatory documents such as IB or CTDs.
Ability to handle complexity in drug development and manage interfaces.
Training in toxicology (board certificate) or pathology (board certificate) or comparable experience provides a high advantage.
Fluency in English, both spoken and written.

EEO Statement

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.