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发帖数: 15 | 1 We are looking for a Senior Pharmacologist for a Pharma company R&D Center
in Shanghai, China.
Title: Senior Pharmacologist
Location: Shanghai, China
Responsibilities:
• Both build new and apply known disease and drug models as stated
previously. This will be based on clinical trial information.
• Design and analyze cross-trial pharmacokinetic-pharmacodyamic
analysis to understand who responds to treatment and who is exposed to risk.
• Simulate new situations (e.g., trial design, efficacy-safety in new
populations) based on prior data and models.
• Provide quantitative analysis for the Asia-Pacific market including
dose-response, trial design, dosage form performance and new patient
subpopulations
• Provide Clinical Pharmacology expertise to project teams for drug
candidates discovered by China R&D
• Provide local China and other Asia Pacific Countries, clinical
pharmacology input for local Phase I/II support for global projects and
Lifecycle Teams.
• Serve as a China liaison with Global Clinical Pharmacologist for the
assigned projects.
• Lead or contribute to cross-functional working groups in the context
of project teams and/or clinical pharmacology activities.
• Develop the timely, scientifically sound, business-required clinical
pharmacology studies to support early stage (Phase I-II) and late-stage
studies or NDA approvals in China and other Asia Pacific Countries.
• Prepare in a timely manner and with high quality the relevant
documentation.
• Deliver high-quality evaluation and interpretation of clinical
pharmacology data (pharmacokinetics, pharmaco-dynamics, safety, dose/
concentration response).
• Interact with investigators with regard to scientific issues.
• Contributes to appropriate budget and manpower planning for the
assigned activities.
• Prepare or contributes to primary publications for the assigned
products.
• Provide technical coaching and mentoring to the junior scientists to
grow in the field of Clinical Pharmacology or Clinical Pharmacology studies
.
• Interact with pre-clinical research and development scientists in
China or in Global to provide reliable clinical pharmacology expertise and
advice to the research teams in China and AP.
• Participate in evaluation of the Clinical Pharmacology Unit or
Clinical Pharmacology CROs, if needed.
• Provide support to train Data Managers, PK/PD Lab managers, Clinical
Monitors for the Clinical Pharmacology studies.
Qualification and Experience:
Minimum:
• PharmD, PhD, or MD in clinical pharmacology, or an area relevant to
clinical pharmacology, with relevant clinical and pharmaceutical industry
experience in the planning and conduct of clinical trials
• Demonstrated ability to conceive, plan, conduct and analyze sparse
samples related to efficacy and safety
• Demonstrated ability to analyze high intensity phase 1 -2 PK-PD
trials for dose selection
• Publication of these studies in peer reviewed journals
• Appropriate computer software experience.
• In-depth knowledge of the global drug development process.
• Capability to learning the China regulatory requirement and process.
How to Apply:
Please send your CV to: a***[email protected]. |
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