Gaithersburg or Boston, US
We are looking for an experienced toxicological pathologist to join the Regulatory Safety Centre of Excellence that sits within the CPSS organisation. While the Regulatory Safety Centre of Excellence is primarily focused on supporting late stage development activities across the entire AstraZeneca portfolio, it also provides early stage support to the Neurosciences and Microbial Sciences therapy areas.
Pathology underpins all non-clinical development, and our pathologists play a key and critical role in delivering on the entire AstraZeneca portfolio. As an experienced toxicologic pathologist, you will be demonstrating your skills to primarily support regulatory submissions throughout the value chain, while also acting as pathology representative on drug projects.
Main Duties and Responsibilities:
- Peer review of outsourced non-GLP and GLP toxicology studies.
- Assessment of the impact of emerging pathology data from toxicology studies with onward communication and recommendations to cross-functional project teams and senior leadership.
- Contribute to the authoring and review of regulatory submissions (IND, CTA, NDA, BLA).
- Support for regulatory defence, pharmacovigilance, due diligence and responses to regulatory authorities.
- Flexibility to support discovery programs (input into the design, implementation and interpretation of early safety and investigative pathology studies, translational pathology, and animal models).
- Maintain a current knowledge of pathology literature, best practices, and industry direction
- Veterinary or Medical Degree plus residency or other specialty training in veterinary anatomic and/or toxicological pathology.
- Post Graduate pathology qualification (ACVP/ECVP or equivalent).
- Extensive experience of toxicologic pathology to include primary read or peer review of acute, sub-chronic, chronic (rodent/non-rodent), and carcinogenicity studies (ideally small molecule and biotherapeutics).
- A minimum of 8 years pharmaceutical experience as a project representative on drug development projects
- First-hand experience of contributing to regulatory submissions and responses to regulatory questions.
- Strong, effective written and oral communication skills including the ability to organize and clearly present complex data and concepts.
- A willingness to champion the use of digital pathology for regulatory toxicologic pathology.
Open date: 22 May 2020
Closing date: 20 June 2020.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.