Senior Reproductive Toxicologist - Clinical Pharmacology and Safety Sciences (CPSS)

AstraZeneca · Gothenburg, Sweden

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Clinical OperationsFull-timeCompany career page

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Role summary

AstraZeneca seeks an experienced Senior Reproductive Toxicologist to provide scientific leadership across drug development programmes. The role involves interpreting toxicology data, supporting regulatory submissions, advising on reproductive safety assessments, and influencing multidisciplinary teams across the development lifecycle.

What they're looking for

5+ years industry experience in developmental and reproductive toxicology
Demonstrated support for late-stage clinical development, marketing applications, and post-marketing activities
Strong knowledge of ICH M3, S5, S6, S9, and S11 regulatory guidelines
Experience with health authority interactions across EMA, PMDA, CDE, and FDA regions
Expertise in interpreting developmental, reproductive, and juvenile toxicology data
Excellent communication and collaboration skills in multidisciplinary teams
Ability to balance scientific rigor with pragmatic decision-making in fast-paced environments

What you'll be doing

Interpret developmental and reproductive toxicology data and translate findings into development strategy
Partner with project teams to support clinical development plans, regulatory submissions, and product labelling
Advise on reproductive safety assessments and inclusion of vulnerable populations in clinical programs
Design and oversee reproductive toxicology programmes supporting global registration strategies
Support regulatory agency interactions and represent AstraZeneca in external scientific forums

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