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Director Reproductive Toxicologist at AstraZeneca Pharmaceuticals LP Company · Katori

Asks for

The ad says“Experience supporting health authority interactions and regulatory submissions across global regions (EMA, PMDA, CDE and FDA).”
The ad says“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.”
The ad says“Experience supporting health authority interactions and regulatory submissions across global regions (EMA, PMDA, CDE and FDA).”
The ad says“Experience supporting health authority interactions and regulatory submissions across global regions (EMA, PMDA, CDE and FDA).”
The ad says“Strong knowledge and practical application of relevant global regulatory guidelines, including ICH M3, S5, S6, S9 and S11.”
The ad says“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.”
The ad says“Strong knowledge and practical application of relevant global regulatory guidelines, including ICH M3, S5, S6, S9 and S11.”
The ad says“Strong knowledge and practical application of relevant global regulatory guidelines, including ICH M3, S5, S6, S9 and S11.”
The ad says“Strong knowledge and practical application of relevant global regulatory guidelines, including ICH M3, S5, S6, S9 and S11.”
The ad says“Strong knowledge and practical application of relevant global regulatory guidelines, including ICH M3, S5, S6, S9 and S11.”
The ad says“Strong knowledge and practical application of relevant global regulatory guidelines, including ICH M3, S5, S6, S9 and S11.”
The ad says“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.”
The ad says“Experience supporting health authority interactions and regulatory submissions across global regions (EMA, PMDA, CDE and FDA).”
The ad says“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.”
The ad says“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.”

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 sites in Gaithersburg or Boston (USA), 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.

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?

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’s Next?

Are you ready to bring transformative science to B-cell leukemia patients? We’d love to hear from you.

The annual base pay (or hourly rate of compensation) for this position ranges from $184,538.40 - 276,807.60 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

14-Sep-2026

Closing Date

14-Oct-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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