Astrazeneca

Pharmaceuticals

StudyMonitor,SafetySciencesChina

$285–475k ~AI est. China FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Study Monitor, Safety Sciences China at Astrazeneca. Skills: Toxicology study monitoring, Regulatory toxicology, In vivo studies. Support design, conduct and reporting of non-clinical in. Provide expert opinion in design and interpretation”

What You'll Achieve.

Deliver life-changing medicines; Deliver expanding portfolio; Deliver pipeline; Enable clinical studies; Enable marketing authorisation; Support data-driven decisions

Industry & Context.

Pharmaceuticals
Problems you'll solve

Data-driven decisions

Eligibility Requirements

Some travel required

What They're Looking For.

Must Have

MSc or BSc in Pharmacology, Toxicology or related Natural Science, Safety assessment experience from non-clinical R&D, Experienced in vivo toxicologist, GLP Study Director and/or Study Monitor experience, Familiar with regulatory toxicology study types, Familiarity with regulatory principles and guidelines

Nice to Have

Experience across therapeutic areas and modalities, Hands on experience working as a GLP Study Director, Hands on experience working as a GLP Study Monitor

What You'll Do.

conduct and reporting of non-clinical in

Provide expert opinion in design and interpretation

Ensure delivery of high quality toxicological data

Enable clinical studies and marketing authorisation

Provide expert input into design

conduct and interpretation

Ensure delivery of high quality toxicological documentation

Oversee toxicology/safety studies run at CROs

execution and reporting

Design and report high quality regulatory studies

Communicate results to cross functional project teams

Serve as accountable point of contact for CROs

Conduct on site study visits

Contribute to and challenge study design concepts

Apply good scientific principles

Utilize experience of in vivo toxicology

Assure ethical and efficient use of resources

Lead regulatory and investigative toxicology study design

Develop strategies to predict safety risks

Mitigate target- and modality-related safety risks

Apply toxicology expertise to predict clinical safety risks

Support data-driven decisions across programs

Provide strategic toxicology input for evaluations

Communicate integrated risk assessments to governance bodies

Contribute to regulatory submissions

Maintain and expand expertise in regulatory standards

Stay ahead of industry trends

Innovate at intersection of regulatory toxicology and science

Leverage emerging technologies

Contribute to internal and external scientific reputation

How You'll Work.

Team & Collaboration

Global group of colleagues; Internal experts; CRO Study Director; Cross functional project teams; Drug project teams; Multidisciplinary matrix teams

Communication Scope

Communicating results; Excellent communication; Influencing skills

Process & Methodology

Project management

Full Job Description

At AstraZeneca, we push the boundaries of science to deliver life-changing medicines. Our global Safety Sciences organization delivers innovative non-clinical safety science and toxicology expertise to enable the discovery, development and registration of novel medicines. We are seeking a highly motivated **Study Monitor ,** to join our Safety Sciences China group to help deliver our expanding portfolio, working within a**** global group of colleagues in the UK, Sweden, USA and India. Ideally we are looking for an experienced _in vivo_ toxicologist, with a background in both the CRO and pharmaceutical industries as a Study Director/Study Monitor. Strong candidates will be familiar with the full range of regulatory toxicology studies required for **international Health Authority submissions** , **across therapy areas, delivery routes, species and a range of modalities (small molecules, radio-conjugates, immune-cell engagers, antibody–drug conjugates, peptides, etc)**. **The Role** Regulatory Toxicology and Safety Pharmacology, AstraZeneca R&D is looking for a Toxicology Study Monitor to support the design, conduct and reporting of non-clinical in vivo studies at Contract Research Organisations (CROs). As a Study Monitor you would work closely with CROs and fellow AstraZeneca scientists to provide expert opinion in the design and interpretation of non-clinical toxicity programmes ensuring the delivery of high quality toxicological data and documentation to enable clinical studies and marketing authorisation of drug candidates. You’ll play a pivotal role in delivering our pipeline, working closely with many stakeholders, including our Project Toxicologists, to provide expert input into the design, conduct and interpretation of non-clinical toxicity studies, ensuring the delivery of high quality toxicological documentation to enable clinical studies and marketing authorisation of our medicines. **Responsibilities** You will have overall responsibility for the **toxicolo

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