Reproductive Toxicologist

Cambridgeshire, Gaithersburg, Maryland, Waltham, Massachusetts
Full time
Posted
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AstraZeneca UK
Healthcare & medical
10,001+ employees
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Reproductive Toxicologist – Clinical Pharmacology and Safety Sciences

Are you passionate about working for a global health care company who truly puts patients first, and would like to apply your toxicology expertise in a company that is accelerating innovative science and turns ideas into life changing medicines?

AstraZeneca discovers and develops medicines in our core areas of Oncology, Respiratory and Immunology, Neuro- & Microbial Sciences and Cardiovascular, Renal and Metabolic Disease . Regulatory Toxicology & Safety Pharmacology is a global department within the Clinical Pharmacology and Safety Sciences (CPSS) function; we’re looking to recruit a talented and experienced reproductive toxicologist to join our reproductive toxicology team.

Driven by innovative science and our entrepreneurial culture, we are focused on developing life changing medicines for our patients. We have a strong pipeline, rich in new modalities pushing the boundaries to show what science can do. Developmental and reproductive toxicology forms an increasingly important aspect of the delivery of new medicines that meet patient needs.

Reproductive toxicologists are subject matter experts in the interpretation of Developmental and Reproductive Toxicology (DART) data advising project teams accordingly and exploiting this knowledge to facilitate regulatory submissions. We work closely with our clinical colleagues to advise on contraception requirements and inclusion of children and women of childbearing potential in clinical trials and advise on labelling. Our exciting pipeline presents opportunities to devise safety assessments in unprecedented areas that require fresh and innovative approaches.

We are seeking a Reproductive Toxicologist to support our portfolio of projects and represent AstraZeneca on external industry working parties. This role can be based at any of the following strategic R&D sites (preferred location Boston or Gaithersburg USA).

As a Reproductive Toxicologist, your main accountabilites will be:

  • To design reproductive toxicology studies to support clinical development and marketing approval across multiple therapy areas. Provide specialist interpretation of reproductive and juvenile toxicology studies and provide input and guidance for non-clinical and clinical governance bodies

  • To provide expert input to product labelling and paediatric investigational plans
  • To contribute to our strategy for reproductive toxicology
  • To represent AstraZeneca on external industry working parties related to reproductive toxicology and paediatric development
  • As a Reproductive Toxicologist, your skills and qualifications will include:at least 5-10 years’ experience working within a Pharmaceutical reproductive toxicological environment
  • Experience of study design, data interpretation and application of non-clinical developmental, reproductive and juvenile toxicology data in GLP studies. Experience of late stage clinical development, regulatory defence and marketing.
  • PhD education (or equivalent) in Toxicology or a related life-science subject
  • Excellent team working skills, able to influence effectively across multidisciplinary teams in a global matrix organisation
  • Understanding and application of regulatory guidelines related to reproductive toxicology and paediatrics and experience of late stage clinical development and marketing
  • Experience of supporting discovery projects and understanding of reproductive toxicity in vitro screens would be advantageous.

In CPSS we aim to stimulate continued creativity throughout our organization by maintaining a culture in which our people feel valued, energized and rewarded for their ideas and contribution to our success. We support and encourage our people in discovering their own potential, through excellent learning and development opportunities that are available to them throughout their careers. The Reproductive Toxicologist role offers many development opportunities working closely with a wide range of non-clinical and clinical scientists across a range of modalities at all phases of development.

Date Posted

13-May-2024

Closing Date

09-Jun-2024Our 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.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.