at Pfizer, Inc in Bentonville, Arkansas, United States
Serves as the Clinical Pharmacology representative for Phase 1 to 4 clinical studies supporting global development of Anti-Infectives.
Provides Clinical Pharmacology support for established product defense and maintenance activities for addressing regulatory queries and labeling updates.
Embraces Model Based Drug Development (MBDD) to facilitate development programs through use of Modeling and Simulation, integrating knowledge of pharmacokinetics, pharmacodynamics, and patient characteristics for adult and pediatric development programs, new indications, and product defense.
Provides clinical pharmacology representation on multi-disciplinary study teams for Anti-Infectives, Hospital products, and post-approval commitments.
Provides clinical pharmacology contributions at a study level (including protocols, analysis plans, clinical conduct, and study reports) and to global regulatory submission documents (IB, IND, pediatric plans, NDA, MAA).
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 established product maintenance.
PhD or PharmD, Fellowship training preferred
At least 5 years of drug development experience (or equivalent) with at least 3 years in clinical pharmacology
In-depth knowledge of pharmacokinetics and related analysis software programs
Knowledge of regulatory guidance documents/standards and experience with regulatory agency interactions
Excellent written and oral communication skills
Organizational awareness (inter-relationship of departments, business priorities, etc.)
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Requires excellent analytical skills
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Ability to travel locally and globally
Other Job Details
Eligible for Employee Referral Bonus
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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.