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发帖数: 306 | 1 代发，If interested, pls contact: d******[email protected]
Seeking a Director of Clinical Pharmacology for a global leading pharma's R&
D in Shanghai, China
Key Responsibilities:
•Contributes to the overall development of long term strategy for
clinical pharmacology in new drug development in China R&D.
•Align & implement clinical pharmacology related strategies to meet
China R&D objectives
•Contribute to clinical pharmacology strategy in early and late stage
studies as well as in regulatory submissions such as Clinical Trial
Applications and NDA submission for China R&D compounds
•Line management responsibilities for professional staff
•Accountable for mentoring, coaching & supervision of direct reports,
where needed
•Assesses development needs for direct reports & establishes personal
development plan
•Contributes to appropriate budget and manpower planning for the
assigned activities
•Support Head of EDCP in development and implement department strategy
and goals achievement
•May support project kineticists on technical analysis
•May participate in development of strategic plans for application of
modeling and simulation throughout drug development
•Design and analyze cross-trial pharmacokinetic-pharmacodyamic
analysis to understand who responds to treatment and who is exposed to risk.
•Provide quantitative analysis for China R&D assets including dose-
response, trial design, dosage form performance and new patient
subpopulations (e.g., pediatrics, elderly)
•Evaluate understand pre-clinical package data for clinical studies,
design, conduct, analyze SD and MD clinical studies and mechanism of action
studies).
•Serve as a China liaison with Global Clinical Pharmacology and
Modeling and Simulation Community
•Lead or contribute to cross-functional working groups in the context
of project teams
and/or clinical pharmacology activities.
•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, etc).
•Deliver high-quality evaluation and interpretation of clinical
pharmacology data
(pharmacokinetics, pharmacodynamics, safety, dose/concentration response).
•Interact with investigators with regard to scientific issues.
•Be responsible for the integrity and high quality of Clinical
Pharmacology studies conducted by China R&D from protocol design, execution,
data analysis and final study report.
•Accountable for quality of Clinical Pharmacology portion of all
regulatory submissions
• Adopt efficient and effective local clinical pharmacology study
working process and experience and implement them in China, in alignment
with the global organization.
•Deliver portions of the NDA documentation, responses to China and
other Countries Regulatory
Agencies questions, and preparation of materials for use in presentation,
for all
interactions with regulatory authorities with regards to clinical
pharmacology issues.
•Prepare or contributes to primary publications for the assigned
products.
•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 R&D.
•Participate in evaluation of the Clinical Pharmacology Unit or
Clinical Pharmacology
CROs, if needed.
•Networks and influences at director/senior management levels (
internal & external)
•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 EDCP initiatives.
Basic Requirements:
•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).
•Experience with advanced data analysis skills (e.g., population PK/PD
or other advanced
Modeling and Simulation Skills).
•In-depth knowledge and understanding of pharmaceutical business
including R&D processes and objectives.
•Ability to advertise practical application of CPMS within R&D
partners.
•Has track record of full clinical pharmacology project representative
responsibility for multiple compounds
•Demonstrated ability to conceive, plan, conduct and analyze sparse
samples related to efficacy and safety
•Publication of these studies in peer reviewed journals
•Appropriate hands-on computer software experience (including
WINNONLIN, NONMEM 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 and other Asian Countries regulatory
requirement and process.
•Able to represent the company and interact with regulatory
authorities.
•Able to work in a ever changing/challenging internal and external
environment
•Excellent verbal, written, presentation and organizational skills.
•Outstanding platform and persuasion skills.
•Speaks and writes fluent English.
Preferred Requirements:
•Successful track record for interfacing with major government
agencies, such as US-FDA or CPMP or EMEA.
•Speaks and writes fluent Chinese. |
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