Director Reproductive Toxicologist

Role: Senior Reproductive Toxicologist providing scientific leadership within AstraZeneca's Regulatory Toxicology and Safety Pharmacology team, supporting drug development from discovery to post-marketing. Responsibilities: interpret developmental, reproductive, and juvenile toxicology data; inform development strategies; support regulatory submissions and health authority interactions; guide reproductive safety assessments and inclusion of women of childbearing potential; oversee reproductive toxicology programs; contribute to regulatory and scientific forums; help evolve reproductive safety strategies with innovative approaches. Requirements: Bachelor's degree in a related field; 5+ years industry experience in reproductive toxicology, supporting regulatory activities including submissions and labelling; strong knowledge of global guidelines (ICH M3, S5, S6, S9, S11); experience interacting with agencies (FDA, EMA, PMDA, CDE); excellent communication skills and ability to influence multidisciplinary teams. Preferred: experience with pediatric development, diverse therapeutic modalities, innovative safety assessment methods, external scientific collaborations. HighValue: Reproductive toxicology, drug development lifecycle, global regulatory engagement, support across phases from discovery to post-marketing, contribution to safety strategy evolution. WorkSetup: primarily US-based (Gaithersburg or Boston), with potential for other strategic locations; details on travel not specified.