Pfizer (China) Research & Development Center, Shanghai
Clinical Pharmacology/Pharmacometrics:
Pharmacometrician I & II (Pharmacometrician I - D2A /
Pharmacometrician II - D2B)
In this key role as a member of our industry leading Global
Pharmacometrics group you will be responsible for conducting and
reporting population PK/PD analyses, following Pfizer best practices, to
support projects of our various Research and Business Unit
organizations. Of key importance will be the formation and maintenance
of effective collaborations with other pharmacometricians and clinical
pharmacology leads of the global Pfizer.
Key Responsibilities:
General Project Support Responsibilities
* To form effective collaborations with clinical pharmacology
leads as well as the project pharmacometricians, in particular disease
area points of contact, to deliver high-quality population PK/PD
analyses to support projects of our various Research and Business Unit
organizations.
* To plan effectively so as to achieve appropriate timescale for
successful completion of each population PK/PD analysis and report,
working in collaboration with appropriate colleagues.
* Based on the analysis outline, draft the population modeling
analysis plan for review and feedback by the project team.
* Consistent with the analysis plan, submit and review dataset
requests to ensure that datasets generated are appropriate for the
analysis plan and are of a sufficient standard to satisfy GCP and
Regulatory Authority submissions.
* To conduct and report population PK/PD analyses, generate
parameters and appropriate diagnostic plots, following Pfizer best
practices.
* To conduct analysis review sessions with the project team, as
necessary, to confirm emerging and draft results.
* To draft the population modeling analysis report, including
all results and appendices, for review and comments by the project team.
* To manage team reviews and updates to finalize the analysis
report appropriately.
* To participate in peer review and quality control activities
as part of the analysis reporting process
* To submit the finalized report to the appropriate document
repository for publishing
Specific Pharmacometric Line Responsibilities
* To share learning's and participate in peer review meetings
with other Pharmacometricians.
* Contribute to the Pharmacometric group remit in implementing
standards in order to achieve consistency in the population PK/PD
analyses across RU/BUs.
* Promote, educate and mentor others in application of
quantitative techniques and participate in and share experiences through
appropriate local and global discussions.
* Work to increase the visibility and effectiveness of
Pharmacometrics, promoting the use of quantitative principles through
active contributions (presentations or publications) at internal and
external meetings.
* To keep abreast of developments in the field of
Pharmacometrics and ensure line colleagues are kept up-to-date with the
relevant scientific developments.
Candidate Specifications:
Ideally you will be a graduate with an applied and/or methodological PhD
or MSc in a relevant field of computer modelling, Pharm.D or M.D,. with
a minimum three years' experience (including graduate training) in
pharmacokinetics/clinical pharmacology/statistics, medicine or a related
discipline and an excellent understanding of the drug development
process. However, candidates from an alternative background e.g.
mathematics, engineering, system biology will be considered if they can
demonstrate relevant experience and expertise.
Data modelling and good communication skills in English (written and
oral presentations) are essential for this role.
The successful candidate will have published or presented in the field
of exposure response modelling and will be familiar with NONMEM and/or
other data analytical tools S-Plus, WinBugs, SAS etc.
On top of above requirements, the successful candidate for
Pharmacometrician II will have about two years or more industry
experience in the popPK/PD modeling, and have real world experiences in
the popPK/PD analysis and reporting in a regulatory compliant
environment.
Competency Requirements:
* A self-motivated, clear thinking person who is well organized
and can operate independently under broad direction.
* A person who can achieve results through effective
collaborations with the teams, and functional groups upon which they
depend for the delivery of population analyses.
* The ability to relate to, and communicate with development and
operational staff across a range of disciplines throughout the company.
* Possession of effective verbal and written English
communication skills in relating to colleagues both inside and outside
the organization.
* The ability to advise and guide colleagues in a supportive and
encouraging fashion ensuring that deadlines are agreed, set and
achieved.
* A diplomatic person who can develop and maintain the existing
good relationships, gain the confidence of other professionals, present
and argue a case, and strongly influence contentious discussions in a
constructive manner.
* Proactive in seeking new information/developments in the
technical arena.
* Keen and able to work in a team environment, with a
collaborative approach to interactions at work.
* Comfortable in mentoring and motivating cross functional teams
in complex quantitative methodologies and techniques.
* Able to adapt quickly to working within a regulated industry,
and to demonstrate flexibility when constraints/conflicts become
evident.
Please send your CV to Lucy Chen of HR Talent Acquisition
([email protected] <mailto:[email protected]> ).