The synergy between advanced knowledge management, quantitative drug
development and advanced statistical study design are central to
Pfizer's drug development strategy. Pfizer has several challenging
positions available globally. These positions are part of a continued
company wide strategic recruitment effort to build on our existing
strengths in applying modeling, simulation and innovative study design
to optimize drug development.
Successful candidates will be hired at a level commensurate with their
level of ability and expertise. The positions represent the spectrum of
potential job roles and there is flexibility to accommodate individual
skill sets and career aspirations.
Clinical Pharmacology Lead (Manager/Associate Director/Director)
Responsibilities:
As a member of cross-functional project teams, responsible for
development and execution of clinical pharmacokinetic
(PK)/pharmacodynamic (PD) plans, including drug-drug and drug-disease
interaction strategies, that will optimize doses, dosage regimens and
study designs throughout clinical drug development. Responsible for
design, analysis, interpretation and reporting of PK and PD studies in
Phases 1 to 3. Integrate knowledge of PK, PD, patient characteristics
and disease, (e.g., mechanism-based PD models and simulations
incorporating such complexities as delayed response, disease progression
or PD tolerance), to enhance decision-making and increase efficiency of
drug development. Prepare Clinical Pharmacology elements of summary
documents for regulatory submissions and contribute to the preparation
and maintenance of Investigator Brochures and Investigational New Drug
applications utilizing knowledge of relevant regulatory guidelines.
Represent Clinical Pharmacology function in meetings with regulatory
authorities. Specific duties will depend on extent of relevant industry
experience.
Qualifications
A doctorate degree in pharmaceutical sciences or related discipline,
with post-graduate experience desirable. Compensation and title will be
commensurate with training and prior experience. A strong theoretical
understanding and demonstrated application of PK/PD principles, with
experience using software such as WinNonlin, NONMEM, SAS, S-Plus/R or
other related PK/PD applications desirable. Excellent oral and written
communication skills, as well as demonstrated ability to work
effectively in a team environment, are essential.
The Clinical Pharmacology Lead positions will enhance the existing
expertise and capacity currently available in New London, Connecticut,
La Jolla, California and Sandwich, UK.
Pharmacometrician (Manager/Associate Director/Director)
Responsibilities
The successful candidate will be part of a global Pharmacometrics
Department working in partnership with therapeutically aligned
multi-disciplinary clinical development teams of quantitative
scientists. Candidates will be responsible for the use of innovative
quantitative methods to integrate knowledge of pharmacokinetics (PK),
pharmacodynamics (PD), patient characteristics and disease states to
optimize doses, dosage regimens, study designs, clinical program designs
and decision-making throughout clinical drug development.
Responsibilities will include elements of the following: modeling of
clinical trial data, including population PK and PK/PD; clinical trial
simulations to support the design of clinical studies; quantitative
evaluation of risk-benefit; meta-analyses of prior clinical trial
results to provide an enhanced quantitative basis for decision-making;
and development of new tools and methodologies that improve
productivity. The successful candidate will also be responsible to
mentor and train colleagues in the application of novel modeling and
simulation methods to ensure Pfizer's position as a leader in model
based drug development.
Qualifications
A doctorate degree in pharmaceutical sciences, statistics or related
discipline, with post-graduate experience desirable. Compensation and
title will be commensurate with training and prior experience. The
ideal candidate should have an extensive modeling and simulation skill
set covering aspects of the following: design and analysis of PK and PD
studies, proficiency in application of nonlinear mixed effects models,
application of mechanistic PK-PD models, disease progression models,
statistics and clinical trial simulations. Candidates must possess very
good skills in the use of several specialized software such as NONMEM,
SAS, S-Plus/R, Winbugs and/or TS2. Excellent oral and written
communication skills, as well as demonstrated ability to work
effectively in a team environment, are essential.
The Pharmacometric positions will enhance the existing expertise and
capacity currently available in New London, Connecticut, La Jolla,
California and Sandwich, UK, as well as the newly created
Pharmacometrics groups based in Seoul and Shanghai (the subject of a
previous advertisement).
Please apply by going to www.Pfizer.com , click the Career tab in the
lower left side, next click on Find a Career at Pfizer, then click on
job opportunities, scroll down and put in 79513 for the Clinical
Pharmacology Lead or 79507 for the Pharmacometrician position.