Pfizer Director, Clinical Pharmacology Lead, Anti in New York City, New York
Serves as the Clinical Pharmacology representative and provides expertise on designated clinical development programs and established products for the Anti-Infective therapeutic area.
Provides Clinical Pharmacology support for product defense and maintenance activities for addressing global regulatory queries and labeling needs.
Implements the use of quantitative approaches (Modeling and Simulation) to integrate knowledge of pharmacokinetics, pharmacodynamics, and patient characteristics for dose selection, pediatric development, new indications, and product defense.
Provides clinical pharmacology leadership on multi-disciplinary teams for Anti-Infective programs, post-approval commitments, and global submissions.
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 PK/PD modeling and simulation plans and interpretation of results.
Provides clinical pharmacology support and leadership in various regulatory interactions.
Responsible for addressing, writing and reviewing regulatory queries and labeling requests to support product maintenance.
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 at conferences.
PhD or PharmD
Post-doctoral training or experience in Infectious Diseases preferred
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
Other eligible locations: La Jolla, CA, Collegeville, PA, Peapack, NJ, Cambridge, MA, Groton, CT, New York, NY, Lake Forest, IL
EEO & Employment Eligibility
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