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Responsibilities
1, Serves as the Clinical Pharmacology representative on drug development and
clinical sub-teams and provides clinical pharmacology expertise and leadership
to projects.
2, Plans and directs clinical pharmacology components of clinical programs
(including clinical development plan and medicine plan) and studies (including
design, synopsis preparation and reporting).
3, Works with multifunctional study team to design, deliver and report the
assigned clinical pharmacology studies and has overall scientific
accountability for the designated studies.
4, Responsible (with Clinicians and Statisticians) for ensuring appropriate
dose-finding strategies during clinical drug development that will ensure
optimal doses and dosage regimens in patients.
5, Accountable for the development and implementation of a clinical modeling
and simulation plan based on agreed-upon best practices (i.e. model-informed
drug development).
6, Responsible for use of quantitative methods to integrate knowledge of
pharmacokinetics, pharmacodynamics, patient characteristics and disease states
to optimize doses, dosage regimens and study designs throughout clinical drug
development.
7, Responsible for appropriate summarization and interpretation of results of
pharmacokinetic/pharmacodynamic (PK-PD) analyses with respect to their impact
on development and clinical use of drugs.
Minimal/Must-have Requirement
Education: Pharm. D., Ph.D., or equivalent training or experience in
pharmacokinetics, pharmacometrics, clinical pharmacology, engineering or
related discipline.
Basic
Qualification: Demonstrates thorough understanding of the following: 1)
principles of PK, PK-PD and pharmacology relevant to drug candidates; 2) other
relevant scientific disciplines, including drug metabolism, drug transport,
formulation sciences, biopharmaceutics, pathophysiologyand therapeutics; and 3)
quantitative modeling and simulation principles.
Communication Skills: demonstrates excellent verbal and written communication
skills (both CN and EN)
Pfizer is an equal opportunity employer and complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.
Medical