Director Reproductive Toxicologist
About the role
Senior Reproductive Toxicologist
Gaithersburg or Boston (USA)
What you'll do
As a Senior Reproductive Toxicologist, you will provide expert scientific leadership and strategic guidance across AstraZeneca's portfolio, supporting programmes ranging from discovery through late-stage development, registration, and post-marketing activities.
Key responsibilities include:
- Providing expert interpretation of developmental, reproductive and juvenile toxicology data and translating findings into development and regulatory strategy.
- Partnering with multidisciplinary project teams to support clinical development plans, regulatory submissions, health authority interactions and product labelling.
- Advising on reproductive safety assessments, inclusion of women of childbearing potential and paediatric populations in clinical development programmes.
- Designing and overseeing reproductive toxicology programmes that support global development and registration strategies across multiple therapeutic areas and modalities.
- Contributing to governance discussions and presenting reproductive toxicology positions to project teams.
- Supporting interactions with global regulatory agencies and contributing to responses to regulatory questions.
- Representing AstraZeneca in external scientific forums, industry collaborations and consortia related to reproductive toxicology and paediatric development.
- Contributing to the continued evolution of AstraZeneca's reproductive toxicology strategy, including innovative approaches that advance science and reduce animal usage.
Minimum Qualifications
We are looking for an experienced reproductive toxicologist with strong scientific judgement, strategic thinking and the ability to influence across multidisciplinary teams.
You will bring:
- Bachelor's degree in a related field.
- Industry experience applying developmental and reproductive toxicology expertise , including experience supporting one or more of: marketing applications, health authority interactions, regulatory submissions or product labelling. Typically gained through 5+ years of relevant experience.
- Demonstrated experience supporting late-stage clinical development, marketing applications, product labelling and 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.
Desirable Qualifications
The following would be advantageous :
- 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.
Why join us?
What’s Next?
Date Posted
Closing Date
Not included in the source posting: about the role.
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