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

Job description

*At AstraZeneca, we are driven by science and united by our commitment to deliver life-changing medicines to patients. With one of the industry's most diverse and successful portfolios spanning multiple therapeutic areas and modalities, we offer a unique opportunity to contribute to drug development from early discovery through to post-marketing support.* We are seeking an experienced **Senior Reproductive Toxicologist** to join our developmental and reproductive toxicology team within **Regulatory Toxicology and Safety Pharmacology, part of Clinical Pharmacology and Safety Sciences (CPSS)**. This is a role for an individual who combines deep reproductive toxicology expertise with the ability to influence multidisciplinary teams and contribute strategically to drug development programmes. Working across a broad portfolio, you will help shape development plans, support regulatory submissions and health authority interactions, guide product labelling strategies, and ensure reproductive safety considerations are appropriately integrated throughout the development lifecycle. The role will ideally be based at one of AstraZeneca's major US R&D site in **Gothenburg (Sweden)**, however other AstraZeneca strategic R&D locations may be considered for exceptional candidates. **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. **Essential requirements** 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: - 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 experience** 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. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. **Why join us?** This role offers a rare opportunity to apply reproductive toxicology expertise across the entire drug development lifecycle. You will work on a diverse portfolio of innovative medicines, engage with a broad network of scientific and clinical experts, and contribute directly to development strategies that impact patients around the world. You'll join a supportive and collaborative team of reproductive toxicology specialists where scientific excellence, partnership and continuous learning are highly valued. Whether supporting regulatory strategy, influencing clinical development, or contributing to industry-wide scientific initiatives, you will play a key role in advancing AstraZeneca's commitment to delivering medicines that make a meaningful difference to patients. **What is next?** We welcome your application, including CV and cover letter, no later than **October 31st, 2026**. Please combine your cover letter and CV into a single document before uploading. **Date Posted** 20-Oct-2026 **Closing Date** 31-Oct-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.