Senior Toxicology Project Lead Eye/Mental Health

Senior Toxicology Project Lead Eye/Mental Health The Position As Senior Toxicology Project Lead Eye/Mental Health you will represent nonclinical drug safety in BI project teams from discovery to submission. Your role includes advising on nonclinical safety for new drugs of different Modalities—covering the nonclinical testing strategy, study design, dose selection, and the overall toxicological assessments (including impurity qualification and qualification of new excipients)—and supporting the preparation of development plans, protocols, reports, and regulatory documents. This position has a hybrid setup with approximately 2-3 days per week on site. This position is part time eligible with 85%. Tasks & responsibilities In your new role, you will serve as the Safety Science Lead within Clinical Pharmacology and Non-Clinical Safety Sciences (CPS) for Mental Health, Eye Health, and Emerging Areas (MH, EH & EA). You will support the implementation of scientifically robust non-clinical safety project strategies, spanning from NTC discovery through clinical trial execution to regulatory submission, specifically for the development of IVT medications in eye health 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 Eye Health and/or Mental Health. 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. Requirements DVM, MD or PhD with specialization or strong working experience in toxicology; board certified and regulatory accepted toxicologist for preparing regulatory documents. Several years of experience in regulatory nonclinical drug safety (toxicology) for human pharmaceuticals in the sector for Eye Health and/or Mental Health with a proven track record in preparing regulatory documents (e.g. IB, IND, DSUR, CTD) and interacting with global health authorities. Disease-area knowledge in at least one Therapeutic area (Eye health and/or Mental health) incl scientific understanding of preclinical models, clinical pathophysiology and therapeutic modalities approved or in development Ability to handle complexity in drug development and the management of interfaces Excellent communication, presentation, organizational and time-management skills, paired with intercultural experience and problem-solving abilities and initiative required Fluency in English, both spoken and written #J-18808-Ljbffr Boehringer Ingelheim GmbH