AstraZeneca

Director Reproductive Toxicologist

AstraZeneca$184K — $276K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a related field.
  • 5+ years of industry experience in developmental and reproductive toxicology.
  • Experience with late-stage clinical development and regulatory submissions.
  • Strong knowledge of global regulatory guidelines (ICH M3, S5, S6, S9, S11).
  • Experience with health authority interactions (EMA, PMDA, CDE, FDA).
  • Expertise in interpreting developmental and reproductive toxicology data.
  • Excellent communication skills for multidisciplinary collaboration.

Responsibilities

  • Provide expert interpretation of toxicology data for regulatory strategy.
  • Partner with project teams for clinical development and regulatory submissions.
  • Advise on reproductive safety assessments in clinical programs.
  • Design and oversee reproductive toxicology programs for global development.
  • Contribute to governance discussions on toxicology positions.
  • Support regulatory agency interactions and question responses.
  • Represent AstraZeneca in external scientific forums and industry collaborations.

Benefits

  • Qualified retirement program (401(k) plan).
  • Paid vacation and holidays.
  • Paid leaves.
  • Health benefits including medical, dental, and vision coverage.
Full Job Description
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.


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
18-Aug-2026

Closing Date
09-Sep-2026

About AstraZeneca

AstraZeneca is a British-Swedish multinational pharmaceutical company that specializes in the research, development, and manufacturing of prescription drugs. The company was formed in 1999 through the merger of Astra AB and Zeneca Group plc. AstraZeneca's products are used to treat a wide range of medical conditions, including cancer, cardiovascular disease, respiratory disease, and diabetes. The company has operations in over 100 countries and employs more than 76,000 people worldwide. AstraZeneca is committed to developing innovative medicines that improve the health and well-being of people around the world.
Learn more about AstraZeneca
Size
83,100 employees
Market Cap
$211.5 billion
Industry
Net Income
$3.1 billion
Founded
1999
5 Year Trend
+10.2%
Revenue
$26.6 billion
NASDAQ

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