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Местоположение Shanghai Downtown, Shanghai Shi, Китай Идентификатор вакансии R-090696 Дата публикации 09/18/2020

Ensure successful conduct and integrity of all in-scope clinical studies (i.e., providing medical monitoring)
- Co-owners of clinical study delivery (with Stats and Clinical Operations)
- Development documents (CIB, protocol and CSR, ETC) content owner
- Analysis and interpretation of clinical study results in partnership with BIS, Clinical Operations and Safety (as well as Clinical Pharmacologist If necessary)
- Forming and running advisory board for portfolio projects; Be responsible for interacting and communicating with China KOLs for China development strategy and protocol design
- Liaise with safety physician for program-level assessment of safety information, evaluation of safety signals, regulatory compliance of safety reporting
- Liaise with clinical pharmacologist on PK/PD programs to ensure the deliverables
- Leading the team in protocol development preparation for review by the Clinical Challenge and Protocol Review Committee
- Setting strategic direction for addressing medical issues in regulatory

submission and communication/interaction
- Be a TA clinical science expert and supporting China regulatory filing and registration
- Be a TA clinical science expert and leading discussions with regulatory officials on clinical science subjects of a given compound
- Be the clinical science physician and providing consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators

A core function on China Product Team representing TA Clinical Science
- Be the interface with GPT MSD/physicians on clinical sciences matters
- Provide clinical science support to BD and AZ China projects on needed base
- Liaise with MA and BD to support pre-launch marketing activities, publications, conferences and early market access to the compounds
- Maintain up-to-date medical/scientific knowledge as well as clinical trial landscape and competitive intelligences in the TA

Profound Therapeutic Area/Disease Knowledge, Pt journey
- Tx guidance
- Compound knowledge
- Regulatory policy and guidance
- Medical monitoring
- Safety reporting and Risk Management Plan
- CSP/CSR content, data analysis and data interpretation
- Presentation & communication skill
- Analytical and problem-solving skill
- AZ clinical development process
- Industry/competitor knowledge

Minimum 5 years of clinical development experience (at least as clinical research physician for 3 years) in pharmaceutical and/or biotech industry
- Prioritize and focus with attentive to detail and excellent analytical skill

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.

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Отличная корпоративная культура, отличные рабочие условия, поддерживающий менеджмент. Возможность ротации внутри компании. Они ценят инклюзивность и разнообразие.