Clinical Pharmacology Lead
• Serves as the Clinical Pharmacology representative on assigned studies, primarily working on COVID-19.
• 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 Global Brands, Sterile Injectables, post-approval commitments, and global BA/BE 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 interactions with regulatory agencies
- Organizational awareness (inter-relationship of departments, business priorities, etc.)
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Medical