Director Reproductive Toxicologist

AstraZeneca; Cambridge; On-site; GBP 75,000 - 110,000; Full time

Job summary

AstraZeneca is seeking a Senior Reproductive Toxicologist to join the Regulatory Toxicology and Safety Pharmacology team. The role is based in Cambridge, UK, with opportunities to contribute to development plans, regulatory submissions and product labelling strategies across a broad portfolio.

You will provide scientific leadership across discovery through post-marketing activities, shaping development plans and ensuring reproductive safety is integrated throughout the lifecycle.

Qualifications

• Extensive experience in developmental and reproductive toxicology.
• Experience supporting regulatory submissions and health authority interactions.
• Strong knowledge of global guidelines (ICH M3, S5, S6, S9 and S11).
• Ability to influence multidisciplinary teams and drive strategy.
• Excellent communication and interpersonal skills.

Responsibilities

• Provide expert leadership across AstraZeneca’s reproductive toxicology portfolio.
• Support regulatory submissions, health authority interactions and product labelling strategies.
• Design and oversee reproductive toxicology programmes supporting global development and registration.
• Contribute to governance discussions and communicate positions to project teams.

Skills

Reproductive toxicology

Regulatory strategy

Cross-functional collaboration

Communication

Job description

Position: Senior Reproductive Toxicologist
Location: Cambridge, UK
Competitive Salary & Excellent Company Benefits

Application Closing Date: 9th October 2026

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 be based at one of AstraZeneca’s major US R&D site in Cambridge (UK), 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:

• Considerable 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.
• 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

• 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?

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.

Our 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.