Pfizer Associate Director in Groton, Connecticut
We have an exciting opening for a Clinical Pharmacology Lead with a PhD or PharmD with at least 5 years of drug development experience. Pfizer is a leader in model-based drug development and you will be an integral member of the Pfizer Clinical Pharmacology team, supporting late stage programs in the Internal Medicine therapy area. The successful candidate will have strong quantitative pharmacology skills with hands-on experience in the implementation of common software tools (e.g., NONMEM, R) for PK and PK/PD analyses. Self-motivation, strong scientific reasoning and communication (both verbal and writing) skills, and the ability to function effectively in a team environment are highly desirable.
The candidate will be working as a CPL to support development projects in Internal Medicine, including designs of the clinical pharmacology or clinical studies, establishing PK/PD plans, performing PK/PD analysis, reporting results, writing Clin Pharm sections of the CSR, supporting the development of submission documents (briefing book, NDA, MAA, etc). The candidate will be responsible for designing/planning Clinical Pharmacology studies in collaboration with other team members.
Act as Clinical Pharmacology representative providing clinical pharmacology expertise to a multidisciplinary study team for a late-stage Internal Medicine program(s).
Participate in implementing model-informed drug development using quantitative approaches to address questions arising during drug development (including dose selection, clinical trial design, special population dosing, benefit/risk assessment).
Work closely with clinicians, statisticians, and clinical operations colleagues to design, conduct and report results of Clinical Pharmacology trials.
Accountable for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, meta-analysis, etc.
Able to interpret PK and PK/PD data and integrate this knowledge into the clinical trials and the overall clinical program.
Responsible for providing the clinical pharmacology components of protocols, clinical development plans and regulatory documents.
Influences environment outside of Pfizer through methods such as publications and presentations.
PhD, Pharm.D. with 5-8 years of drug development experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics
Strong quantitative skills and expertise (e.g. experience in population modeling, literature meta-analyses, and clinical trial simulations) with hands-on implementation of tools such as NONMEM, R, SAS, or WinBUGS for data analysis and handling
Effective verbal and written communication skills are essential for the role.
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