j******8
发帖数: 12 | 1 We are working with a top Multinational Pharmacy Company to recruit Clinical
Pharmacologist for their R&D center in China (Beijing or Shanghai),
especially in Phase 1/Clinical Pharmacology/PK/PD studies and Clinical
Pharmacology strategy. This position belongs to Early Research Development
Department.
Primary Responsibilities:
• Both build new and apply known disease and drug models as stated
previously. This will be based on clinical trial information inside Roche as
well as the literature
• 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 (e.g., pedatrics, elderly)
• Provide Clinical Pharmacology expertise to p-RED project teams
for drug candidates discovered by China R&D.
• Evaluate understand pre-clinical package data for EIH studies,
design, conduct, analyze SD and MD EIH studies and mechanism of action
studies) .
• 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 (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 by p-RED.
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, in
alignment with the global organization
(p-RED).
• Deliver portions of the NDA documentation, responses to Asia
Pacific Regulatory
Agencies questions, 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.
• If deemed appropriate, providing group lectures, individual
coaching or constructive
feedback to colleagues who are new to the concept of Clinical Pharmacology
in Asia-
Pacific 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 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.
• Participate and represent clinical pharmacology on due diligence
team
• Participate and contribute to the ED &CP Asia Pacific or Global
Department initiatives.
Qualification and Experience:
Minimum:
• PharmD, PhD, or MD in clinical pharmacology, or an area relevant
to clinical
pharmacology, with relevant 8 years clinical and pharmaceutical industry
experience in the
planning and conduct of clinical trials (preferably early human studies in a
pharmaceutical industry setting).
• Relevant expertise in nonlinear mixed effects modeling of
clinical trial data focused on population PK-PD modeling
• 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 (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.
• Able to represent Roche interact with regulatory authorities.
• Hands on approach to daily work.
• Able to work in a quickly changing, not fully structured internal
and external environment
Kind regards,
Jane Lee 李艳
HR Consultant
GEN Enterprise Management Consulting Co., Ltd.
Tel：+86 21 5155 8084 ext 839 Email：j****[email protected] | j******8
发帖数: 12 | 2 没人跟帖呀？哎。同学们，帮忙转转哈~职位级别蛮高，薪酬可谈空间也大。
顺便说下今年罗氏Early Development招聘人数82人；海外做完博士后的就行。欢迎回
国哈O(∩_∩)O | p*********1
发帖数: 206 | |
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