Director Reproductive Toxicologist

AstraZeneca • Cambridge, MA

7d • $184,538 - $276,808 • Hybrid

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior