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Principal Pharmacologist / Associate Director, Pharmacologist

Местоположение Shanghai Downtown, Shanghai Shi, Китай Идентификатор вакансии R-104686 Дата публикации 04/07/2021

Description

-    Provide CP expertise and leadership in clinical development programs, including:
•    Design and conduct clinical studies including CP studies (dosing rationales, sampling schemes, etc.)
•    Data analyses (e.g., M&S) to elucidate dose-exposure-response relationships, and result interpretations
•    Preparation and defence of regulatory submissions
-    Compile and contribute to sections of drug development and registration documents such as clinical trial protocols and reports, drug package inserts and regulatory submission packages, etc. 
-    Interact with internal and external stake holders for assigned projects:
•    Serve as a China liaison with Global CP
•    Serves as core member of the China Project Team
•    Interact with investigators for scientific issues
-    Responsible for delivering quantitative pharmacology and M&S supports to clinical development projects:
•    Play a central role in predicting human dose range, characterizing dose-exposure-response relationship, justifying dose recommendations for special populations, and evaluating ethnic sensitivity
•    Develop mathematical and statistical models to understand disease mechanism, its progression, and PK/PD; conduct meta-analyses as appropriate to maximize data use
-    Train junior CP staff
-    Support establishing best practices for CP activities (e.g., M&S)
-    Evaluate in-licensing opportunities for clinical PK and PK/PD components when needed
-    Literature research and knowledge sharing

Required

-    Ph.D/PharmD/MD in relevant disciplines (CP, pharmacokinetics (PK), pharmacometrics) or other equivalent degrees or knowledge/expertise
-    3+ years of relevant industry experience in CP and Modeling & Simulation (M&S) role
-    Early and late phase clinical development experience 
-    Proven track records and skills in PK, Pharmacodynamics (PD) and longitudinal disease modelling; and proficiency in pharmacometric tools (e.g., NONMEM, R, Monolix, etc.)
-    Adequate understanding of related disciplines (e.g., DMPK, toxicology, biostatistics, medical, regulatory) in drug development
-    Excellent communication and negotiating skills
-    Ability to function effectively in a highly cross-functional team and dynamic environment
-    Fluent in English (oral and written)
-    Team working spirit with self-motivation

【AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised. 
阿斯利康是一家提供平等机会的企业,我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份(如果适用)及任何其他受法律保护的特征而产生歧视。】



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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