Pfizer Manager, Clinical Pharmacology in Boulder, Colorado
Clinical Pharmacology Leads at Pfizer are key members of multidisciplinary drug development project teams who provide subject matter expertise in quantitative pharmacology and are uniquely positioned to work at a technical level while having the opportunity to influence drug development strategy within the organization. Working closely with colleagues across research and development Clinical Pharmacology Leads apply their technical expertise to analyze, develop, validate and implement quantitative models to inform key drug development decisions. They are also responsible for design, conduct, oversight and reporting of clinical pharmacology components of clinical programs and studies.
We are seeking to hire a Clinical Pharmacology Lead to join the Clinical Pharmacology Oncology team within the Early Clinical Development, based in Boulder, CO. The individual will be responsible for developing and delivering the translational modeling/simulation and clinical pharmacology strategies for early oncology programs using state-of-the-art quantitative methodologies to integrate knowledge of cancer biology, pharmacology, pharmacokinetics (PK), pharmacodynamics (PD) and disease-progression. The ideal candidate will have some prior industry experience in clinical pharmacology with expertise in PK/PD or PBPK modeling.
Develop model-informed drug development (MIDD) plan and clinical pharmacology plan for early oncology drug development programs.
Act as clinical pharmacology subject matter expert on multidisciplinary teams working closely with clinicians, biostatisticians, translational oncology, and clinical operations colleagues to design, conduct and report clinical trials from first-in-patient to proof-of-concept; responsible for clinical pharmacology components including pharmacokinetics, pharmacodynamics, food effect (oral compound), drug-drug interaction and QTc.
Collaborate with preclinical scientists to design informative preclinical studies and perform model-based data analyses to predict human PK/PD and anticipated efficacious dose/exposure levels.
Provide scientific justification for optimal human starting dose and dose escalation schemes for oncology first-in-patient protocols based on all available preclinical information including toxicology, efficacy models, physicochemical and biochemical characterization.
Work closely with assay specialists to ensure that appropriate and validated bioanalytical assays are available on time to determine drug concentrations for animal toxicology and clinical studies.
Conduct PK data analysis and develop computational models from PK/PD, safety and efficacy data collected in early stage clinical trials to support key program decision-making.
Present clinical pharmacology results to internal and external stakeholders.
Author clinical pharmacology components of clinical documents including INDs, protocols, investigator brochures, clinical development plans, and study reports; author scientific publications.
Align with global clinical pharmacology groups at Pfizer to maintain consistency with best practices and ensure the state-of-the-art quantitative approaches are being applied to inform key drug development decisions.
Advanced degree (Ph.D., Pharm.D., MD) or equivalent experience in Pharmacokinetics, Pharmacometrics, or other related disciplines.
A minimum of 1 year of industry or equivalent experience in clinical pharmacology and/or pharmacometrics and/or translational modeling.
Proficiency in mathematical modeling and programming as demonstrated by hand-on experience in computational tools (e.g. R, NONMEM, SimCYP/GastroPlus)
Demonstrated ability to work in a highly collaborative, multi-disciplinary, and multi-site team setting.
Excellent verbal and written communication skills.
Self-directed and highly-motivated researcher, with willingness to learning new tools and approaches.
- Prior experience in oncology is desirable.
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