Pfizer Sr Manager, Clinical Pharmacology Lead in Groton, Connecticut
Serves as the Clinical Pharmacology representative on assigned studies.
Provides Clinical Pharmacology support for product defense and maintenance activities for addressing regulatory queries and labeling needs.
Implements the use of Modeling and Simulation to integrate knowledge of pharmacokinetics, pharmacodynamics, and patient characteristics for pediatric development, new indications, and product defense.
Provides clinical pharmacology support on multi-disciplinary study teams for sterile injectables/Biosimilar/Anti-Infectives programs, post-approval commitments, and global bioequivalence studies.
Provides clinical pharmacology components at study level (including protocol preparation, clinical conduct, and reporting).
Responsible for interfacing with partner lines (e.g. clinical assay group, statistics, pharmacometrics) to ensure appropriate support for assigned programs and studies
Accountable for ensuring appropriate design and implementation of a clinical modeling and simulation plan and interpreting results.
Assures that the clinical pharmacology strategy serves the overall objectives of the clinical program and is designed and executed to the highest scientific standards and delivers the data required to fulfill regulatory requirements.
Influences environment outside of Pfizer through methods such as publication and presentations.
Responsible for addressing, writing and reviewing regulatory queries and labeling requests to support maintenance.
PhD or Pharm D
At least 5 years of drug development experience with at least 3 years in clinical pharmacology or preclinical PK and drug metabolism.
Experience in managing Modeling and Simulations activities.
Experience in interactions with regulatory agencies
Organizational awareness (inter-relationship of departments, business priorities, etc.)
Ability to travel locally and globally
EEO & Employment Eligibility
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