Director Reproductive Toxicologist
$184,538–$276,808 year
On-siteGaithersburg, Maryland, United States
Job Summary
Provide expert interpretation of developmental, reproductive, and juvenile toxicology data to translate findings into development and regulatory strategy. Partner with multidisciplinary teams to support clinical development plans, regulatory submissions, health authority interactions, and product labelling strategies. Advise on reproductive safety assessments, inclusion of women of childbearing potential, and paediatric populations in clinical programmes. Design and oversee global reproductive toxicology programmes that support registration across multiple therapeutic areas and modalities. Contribute to governance discussions, present positions to project teams, and represent AstraZeneca in external scientific forums and industry consortia. This role supports AstraZeneca's commitment to delivering life-changing medicines through strategic guidance across the drug development lifecycle, from early discovery to post-marketing activities.
Required Qualifications
- Bachelor's degree in a related field
- Industry experience applying developmental and reproductive toxicology expertise
- Experience supporting marketing applications
- Experience supporting health authority interactions
- Experience supporting regulatory submissions
- Experience supporting product labelling
- 5+ years of relevant experience
- Demonstrated experience supporting late-stage clinical development
- Experience supporting marketing applications
- Experience supporting product labelling
- Experience supporting post-marketing activities
- Strong knowledge and practical application of relevant global regulatory guidelines, including ICH M3, S5, S6, S9 and S11
- Experience supporting health authority interactions and regulatory submissions across global regions (EMA, PMDA, CDE and FDA)
- Demonstrated expertise in the interpretation and strategic application of developmental, reproductive and juvenile toxicology data
- Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively within multidisciplinary global teams
- The ability to balance scientific rigour with pragmatic decision-making in a fast-paced development environment
Desired Qualifications
- Experience supporting paediatric development programmes
- Exposure to a broad range of therapeutic modalities
- Experience supporting innovative approaches to reproductive safety assessment
- Experience participating in external scientific working groups, consortia or industry initiatives
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