Senior Reproductive Toxicologist - CPSS

About the role

AstraZeneca is seeking an experienced Senior Reproductive Toxicologist to join its developmental and reproductive toxicology team within Regulatory Toxicology and Safety Pharmacology, part of Clinical Pharmacology and Safety Sciences (CPSS). The role provides expert scientific leadership across the drug development lifecycle, from discovery through registration and post-marketing, and ideally sits at one of the company's major US R&D sites in Gothenburg, Sweden, though other strategic R&D locations may be considered.

Key responsibilities

• Interpret developmental, reproductive and juvenile toxicology data and turn findings into development and regulatory strategy
• Support clinical development plans, regulatory submissions, health authority interactions and product labelling with multidisciplinary project teams
• Advise on reproductive safety assessments and the inclusion of women of childbearing potential and paediatric populations in clinical programmes
• Design and oversee reproductive toxicology programmes supporting global development and registration across therapeutic areas and modalities
• Contribute to governance discussions and present reproductive toxicology positions to project teams
• Support interactions with global regulatory agencies and responses to regulatory questions
• Represent AstraZeneca in external scientific forums, industry collaborations and consortia on reproductive toxicology and paediatric development
• Help evolve the reproductive toxicology strategy, including approaches that reduce animal usage

Required profile

• Industry experience applying developmental and reproductive toxicology expertise, typically gained over 5+ years
• Demonstrated experience supporting late-stage clinical development, marketing applications, product labelling and post-marketing activities
• Experience supporting health authority interactions and regulatory submissions across global regions (EMA, PMDA, CDE and FDA)
• Excellent communication and interpersonal skills, able to influence and collaborate in multidisciplinary global teams

Required skills

• Strong knowledge of global regulatory guidelines, including ICH M3, S5, S6, S9 and S11
• Expertise in interpreting and applying developmental, reproductive and juvenile toxicology data
• Ability to balance scientific rigour with pragmatic decision-making in a fast-paced environment

Desirable: paediatric development experience, exposure to many therapeutic modalities, experience with innovative reproductive safety assessment approaches, and participation in external scientific working groups or consortia. Applications with CV and cover letter are due by 31 October 2026; the company works at least three days per week from the office.