Shanghai, Shanghai, China · On-site
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 discove…
Skills: In Vivo Toxicology, Study Monitoring, GLP Compliance, Regulatory Toxicology, Safety Pharmacology
Taiwan · On-site
職務說明 透過醫院通路，提供處方藥品之專業諮詢服務，並執行銷售任務。維繫並持續強化客戶關係，反應客戶及市場需求，以確保達到業績目標。 資歷 卓越的專家客戶認可的顧問服務與合作夥伴的口碑；卓越的區域內績效目標達成與成長的表現產品趨勢與競爭對手策略分析能力領導跨部門團隊合作來達成策略目標的經歷自然學科學位；藥學、藥理學為佳具專業的簡報能力個性活潑親和力佳、積極進取、執行力佳且勇於接受挑戰 Date Posted 18-Jun-2026 Cl…
Skills: Pharmaceutical Sales, Customer Relationship Management, Market Analysis, Competitor Strategy Analysis, Cross-functional Team Leadership
China · On-site
工作目的 在所负责的业务区域内, 利用医学专业知识和科学领导力，以患者为中心，建立稳固的合作共赢关系，实现产品的学术交流有效性，合规合法地推动业务可持续的增长。 主要职责 1. 拟订医药产品推广计划和方案； 2. 向医务人员传递医药产品相关信息； 3. 协助医务人员合理使用本企业医药产品； 4. 收集、反馈药品临床使用情况及医院需求信息。 5. 医学代表可通过下列形式开展学术推广等活动： • 在医疗机构当面与医务人员和药事人员沟通； •…
Skills: Medical Knowledge, Scientific Leadership, Academic Promotion, Interpersonal Communication, Problem Solving
China · On-site
Brand communication strategy development Support AD to develop communication strategy for GUGY and GI businesses to align with OBU business objectivesDesign and initiate PR and communication programs based on the strateg…
Skills: Brand Communication Strategy, Public Relations, Crisis Management, Media Relations, Internal Communication
Gaithersburg, Maryland, United States · On-site
$170k–$255k/yr
Join Early Oncology’s Translational Medicine (TM) Global Operations team to drive on quality across our Translational Medicine and Biomarker Science & Technology (BST) organizations, including Labs, Biomarker Operations,…
Skills: Quality Management System, Compliance, Risk Management, CAPA Management, ICH-GCP
Hessen, Saxony-Anhalt, Germany · On-site
Innovativ, dynamisch und nachhaltig: Als eines der weltweit führenden Unternehmen der forschenden Arzneimittelindustrie bieten wir bei AstraZeneca die besten Möglichkeiten für Ihre persönliche und berufliche Entwicklung.…
Skills: Account Management, Therapeutic Consulting, Market Analysis, Strategic Customer Development, Communication Skills
Hamilton, Ontario, Canada · On-site
$82k–$108k/yr
Fusion Pharmaceuticals, a member of the AstraZeneca Group, is advancing next generation radio conjugates as precision medicines for cancer. By combining Fusion’s deep radiopharmaceutical expertise with AstraZeneca’s glob…
Skills: Mammalian Cell Culture, Immunohistochemistry, Flow Cytometry, ELISA, Western Blotting
China · On-site
工作目的 在所负责的业务区域内, 利用医学专业知识和科学领导力，以病患为中心，建立稳固的合作共赢关系，实现产品的学术交流有效性，推动业务可持续的增长。 主要职责 拟订医药产品推广计划和方案； 向医务人员传递医药产品相关信息； 协助医务人员合理使用本企业医药产品； 收集、反馈药品临床使用情况及医院需求信息。 医学代表可通过下列形式开展学术推广等活动： 在医疗机构当面与医务人员和药事人员沟通；举办学术会议、讲座；提供学术资料；通过互联网或者…
Skills: Medical Knowledge, Scientific Leadership, Academic Promotion, Interpersonal Communication, Problem Solving
China · On-site
Typical Accountabilities: • Maintains the processes and technology used to monitor and manage external alliances and relationships between AstraZeneca and other academic and commercial organisations • Acts as a source of…
Skills: External Alliance Management, Relationship Management, Project Management, Risk Mitigation, Stakeholder Coordination
Ho Chi Minh City, Vietnam · On-site
Clinical Study Administrator - HCM The ideal candidate is a passionate, self-motivated, and detail-oriented team player who is committed to the success of our customers. Then AstraZeneca might be the one for you! About A…
Skills: Clinical Study Administration, Document Management, ICH-GCP Guidelines, eTMF Maintenance, Regulatory Submissions
China · On-site
Typical Accountabilities: • Maintains the processes and technology used to monitor and manage external alliances and relationships between AstraZeneca and other academic and commercial organisations • Acts as a source of…
Skills: External Alliance Management, Relationship Management, Project Management, Risk Mitigation, Stakeholder Coordination
Beijing, Beijing, China · On-site
Responsible for providing technical leadership as compound or indication lead within a cross-functional team to design, execute, analyse and interpret clinical studies. Ensures projects (including multiple studies) adher…
Skills: Clinical Trial Design, Clinical Study Execution, Good Clinical Practice, Regulatory Requirements, Protocol Development
China · On-site
Typical Accountabilities: • Maintains the processes and technology used to monitor and manage external alliances and relationships between AstraZeneca and other academic and commercial organisations • Acts as a source of…
Skills: External Alliance Management, Relationship Management, Project Management, Risk Mitigation, Stakeholder Coordination
China · On-site
SUMMARY OF THE ROLE As the core engine of our digital transformation, the Omnichannel Marketing Strategy and Execution Lead will comprehensively orchestrate and drive the company's digital marketing strategy. This role i…
Skills: Omnichannel Marketing Strategy, Digital Transformation, Marketing Automation, WeChat Ecosystem, WeCom Operations
Hamburg, Germany · On-site
Innovativ, dynamisch und nachhaltig: Als eines der weltweit führenden Unternehmen der forschenden Arzneimittelindustrie bieten wir bei AstraZeneca die besten Möglichkeiten für Ihre persönliche und berufliche Entwicklung.…
Skills: Nuclear Medicine, KOL Management, Clinical Study Setup, Medical Writing, AMNOG Benefit Assessment
Bucharest, Romania · On-site
Key Account Manager – Rare Diseases – Bucharest AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines …
Skills: Account Management, Clinical Demand Generation, Stakeholder Engagement, Strategic Relationship Building, Scientific Communication
Seoul, South Korea · Hybrid
Job Description Execute Medical Affairs Plan: Implement territorial activities aligned with global and local medical strategies for pre-launch and launch phases. Scientific Engagement: Provide accurate, balanced and time…
Skills: Scientific Engagement, KOL Management, Medical Affairs Strategy, Clinical Trial Data Interpretation, Evidence Generation
Hamburg, Germany · On-site
Innovativ, dynamisch und nachhaltig: Als eines der weltweit führenden Unternehmen der forschenden Arzneimittelindustrie bieten wir bei AstraZeneca die besten Möglichkeiten für deine persönliche und berufliche Entwicklung…
Skills: Forecasting, Market Research, Data Analytics, AI Implementation, Stakeholder Management
Argentina · On-site
Es responsable por la entrega de los estudios en los sitios asignados y participa en los equipos de estudio locales. El CRA trabaja en estrecha colaboración con otros CRA y el Equipo de estudio local / Gerente de estudio…
Skills: Clinical Monitoring, Good Clinical Practice (GCP), Site Management, Patient Recruitment, Data Quality Management
China · On-site
Typical Accountabilities: • Successfully complete all training requirements, including product examinations. • Engage Oncology professionals in dialogue about approved indications and product efficacy/safety profiles to …
Skills: Oncology Sales, Pharmaceutical Sales, Business Planning, Market Analysis, Sales Forecasting
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Oversee the design, conduct, and reporting of non-clinical in vivo toxicology studies at Contract Research Organisations (CROs). Provide expert scientific input to ensure high-quality data for clinical studies and marketing authorizations.
Requires a BSc or MSc in Pharmacology, Toxicology, or a related Natural Science with hands-on experience as a GLP Study Director or Study Monitor. Must be familiar with global regulatory toxicology standards across various modalities and species.
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 toxicology/safety studies run at CROs. You will be expected to work as an empowered and accountable member of the study team, supporting all aspects of study design, execution and reporting.
You should:
Understand the practices, principles and concepts associated with planning and delivering a fit for purpose non-clinical study program.
Work closely with AZ Project Toxicologists, other internal experts and the CRO Study Director to design and report high quality regulatory studies to agreed deadlines, communicating results to cross functional project teams.
Be the accountable point of contact for communication with CROs at all stages of studies, including on site study visits (some travel therefore required).
Work as an expert on in vivo studies; contribute to and challenge study design concepts applying good scientific principals and utilising your experience of in vivo toxicology.
Assure the most ethical and efficient use of resources (animals, time, money, people).
Be result oriented and efficient, and excel at communicating and project management. You are proactive, organised and a systematic team worker used to working in matrix environments.
Embrace change and thrive in a dynamic working environment that is evolving to meet the needs of the business and the patient.
Job description
Lead regulatory and investigative toxicology study design, developing strategies to predict, assess, and mitigate target- and modality-related safety risks.
Apply your toxicology expertise to predict clinical safety risks and, as core member of drug project teams, support data-driven decisions across discovery and development programs.
Provide strategic toxicology input for in-licensing evaluations and external collaborations.
Communicate integrated risk assessments to governance bodies and contribute to regulatory submissions.
Maintain and expand expertise in regulatory standards, preclinical safety, and modality-specific safety science, staying ahead of industry trends.
Innovate at the intersection of regulatory toxicology and cutting-edge science, leveraging in vitro, in silico, in vivo, and emerging technologies like organ-on-chip, imaging, and omics, and contribute to internal and external scientific reputation through internal and external collaborations, publications, and thought leadership.
Role model demonstration of AZ Values.
Required expertise and experience
MSc or BSc in Pharmacology, Toxicology or a related Natural Science discipline.
Safety assessment experience from non-clinical research and development work within the pharmaceutical and/or CRO industry.
Experienced in vivo toxicologist with hands on experience working as either a GLP Study Director and/or Study Monitor for in vivo non-clinical toxicology studies.
Strong candidates will be familiar with the full range of regulatory toxicology study types (across global health authorities) including all delivery routes, species and a range of modalities.
Experience across therapeutic areas and modalities (small molecules, radio-conjugates, immune-cell engagers, antibody–drug conjugates, peptides) is desirable.
Good command of pharmacological and/or toxicological principles and methods and the ability to rapidly familiarise with new therapeutic approaches.
Familiarity with, and the application of, appropriate regulatory principles and guidelines and the enthusiasm to work within and contribute to the discipline of Toxicology in a drug development setting.
A dedicated team player with excellent communication and influencing skills with experience working in multidisciplinary matrix teams.
Results orientated with high scientific standards in combination with a delivery focus to support project execution.
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 authorization and employment eligibility verification requirements.
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
