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Pfizer, Inc. Clinical Pharmacology Lead in Minneapolis, Minnesota

ROLE SUMMARY A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. We have an exciting opening for a Clinical Pharmacology Lead with a PhD or PharmD with at least 10 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 broad extensive knowledge of clinical pharmacology, drug development, regulatory requirements as well as 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. ROLE RESPONSIBILITIES Provide clinical pharmacology leadership at the asset and/or portfolio level. Identify opportunities where model-informed drug development (MIDD) approaches can advance the understanding of pharmacological activity, efficacy and safety for projects and across the portfolio. Act as Clinical Pharmacology representative providing clinical pharmacology expertise to a multidisciplinary study team for a late-stage Internal Medicine program(s). Leadership in implementing quantitative approaches to address questions arising during drug development (including dose selection, clinical trial design, special population dosing, benefit/risk assessment). Work closely with Clinical, Statistics, Pharmacometrics, 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. 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. Influence environment outside of Pfizer through methods such as publications and presentations. Provide input to the strategy around development of standards, new methodology, tools, software, hardware, and related business processes Train, develop, and mentor other clinical pharmacology colleagues. BASIC QUALIFICATIONS PhD, Pharm.D. with 10 years or more 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. Excellent written and verbal communication skills. Candidates from alternative backgrounds (e.g. mathematics, engineering, system biology, medicine) will be considered if they can demonstrate relevant experience and expertise. PREFERRED QUALIFICATIONS Strong publication record in relevant discipline Experience with regulatory submissions In addition to professional challenge, we offer a culture that supports and encourages ideas, and recognizes individual contribution. Candidate demonstrates a breadth of