Pfizer Director, Clinical Pharmacology Lead in Groton, Connecticut
Serves as the Clinical Pharmacology representative and provides expertise on designated clinical programs and studies for various therapeutic areas and portfolio segment teams (e.g. biosimilar, sterile injectable, or anti-infectives) for established products.
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 leadership on multi-disciplinary study teams for sterile injectables/Biosimilar/Anti-Infectives programs, post-approval commitments, and global bioequivalence studies.
Provides clinical pharmacology components at a project level (including clinical development plan) and 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.
Provides clinical pharmacology support and leadership in various regulatory interactions.
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.
Responsible for implementing clinical pharmacology best practices.
Represent clinical pharmacology to senior levels of the organization.
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 10 years of drug development experience with at least 5 years in clinical pharmacology
Demonstrated success in managing clinical pharmacology activities and Enhanced Quantitative Drug Development (Modeling and Simulations)
Experience in interactions with regulatory agencies globally
Considerable organizational awareness (inter-relationship of departments, business priorities, etc.)
Requires excellent analytical skills
Ability to travel locally and globally
- Eligible for employee referral bonus
EEO & Employment Eligibility
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