跨国500强医药R&D中心招聘Clinical Pharmacologist

你好朋友们，我正在帮一家跨国500强医药R&D中心招聘Clinical Pharmacologist，工
作地点在上海和北京。有意愿的朋友请和我联系，有这方面的朋友也可以帮我推荐，谢
谢。
Email:sun_008@hotmail.com Cell:13439189716

The Position:
Provide Clinical Pharmacology expertise in PDZ project teams
Serve as a China liaison with Global Clinical Pharmacologist for the
assigned projects
Develop the timely, scientifically sound, business-required clinical
pharmacology studies to support late-stage studies or NDA approvals in China
Prepare in a timely manner and with high quality the relevant documentation
(protocols and amendments, CSRs), or the clinical pharmacology component of
other high level documents such as INDs, IDBs, NDA/PLA expert reports,
Chinese package inserts)
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
Be responsible for the integrity of Clinical Pharmacology studies conducted
at PDZ from protocol design, execution, data analysis and final study report
perspective is at the best global level.
Adopt efficient and effective global local clinical pharmacology study
working process and experience and implement them in China.
If deemed needed, with the support from Supervisors and other members in PDZ
, develop local or regional Clinical Pharmacology study process and
procedures to deliver quality, efficiency and cost-effectiveness.
Deliver responses to regulatory agency questions, portion of the NDA
documentation and preparation of materials for use in presentation, for all
interactions with regulatory authorities with regards to clinical
pharmacology issues
Contributes to appropriate budget and manpower planning for the assigned
activities
Prepare or contributes to primary publications for the assigned products
Support the assigned product during the launch phase as demanded by the
business organizations
Provide technical coaching and mentoring to the junior scientists to grow in
the field of Clinical Pharmacology or Clinical Pharmacology studies
Providing group lectures, individual coaching or constructive feedback to
colleagues who are new to the concept of Clinical Pharmacology in PDZ
project teams.
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.
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.
Participate and contribute to the PDZ or global department initiatives

Who you are:
You're someone who wants to influence your own development. You're looking
for a company where you have the opportunity to pursue your interests across
functions and geographies, and where a job title is not considered the
final definition of who you are, but the starting point.

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 (preferably early human
studies in a pharmaceutical industry setting)
Appropriate computer software experience (including WINNONLIN or other
similar PK analysis tool, MS Word, Excel, PowerPoint, etc)
In-depth knowledge of the global drug development process
Capability to learning the China regulatory requirement and process
Experience with advanced data analysis skills (e.g., population PK/PD or
other advanced Modeling and Simulation Skills)
Outstanding hands on track record in driving negotiations with both internal
and external stakeholders
Recognizing as an experienced expert within Clinical Pharmacology community
through challenging project breakthrough work, or significant contribution
to a therapeutic area or drug development process
Successful track record for interfacing with major government agencies, such
as US-FDA or CPMP or EMEA
Desire to actively "coach" and to collaborate.
Speaks and writes fluent English & Chinese.