Clinical Pharmacology (CP) team in AstraZeneca R&D China is looking for several highly motivated clinical pharmacologists from principal scientist to associate director level. CP team is responsible for all aspects of clinical pharmacology-related support for small molecules and biopharmaceutical products at various stages of clinical development.
This position serving as a senior member of the CP team to provide strategic and scientific CP support for clinical development programs in multiple therapeutic areas (TA), interacting with regional and global project teams as well as senior management. If you are interested in this position, please email your resume to Junjie Ding ([email protected]<mailto:[email protected]>) and Daphel Li ([email protected]<mailto:[email protected]>) DUTIES & RESPONSIBILITES * Provide CP expertise and leadership in clinical development programs, including: 1. Design and conduct clinical studies including CP studies (dosing rationales, sampling schemes, etc.) 2. Data analyses (e.g., M&S) to elucidate dose-exposure-response relationships, and result interpretations 3. 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: 1. Serve as a China liaison with Global CP 2. Serves as core member of the China Project Team 3. 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 JOB REQUIREMENTS * 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 * Fluent in English (oral and written) * Team working spirit with self-motivation Junjie Ding, PhD Clinical Pharmacology Department AstraZeneca R&D China
