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 Manager, Clinical Pharmacology Lead to join the Clinical Pharmacology team within the Early Clinical Development Clinical Pharmacology group, supporting our Research Units in Cambridge, MA. With some guidance from senior leads, the individual will be responsible for developing and implementing the Clinical Pharmacology Plan and Modeling-Informed Drug Development strategies for early stage drug development programs, using state-of-the-art quantitative methodologies to integrate knowledge of biology, pharmacology, pharmacokinetics (PK), pharmacodynamics (PD) and disease-progression.
Help develop clinical pharmacology plan for early stage drug development programs, including both small and large molecules with some guidance from senior leads.
Act as clinical pharmacology subject matter expert on multidisciplinary teams working closely with clinicians, biostatisticians, precision medicine and clinical operations colleagues to design, conduct and report clinical trials from first-in-human to proof-of-concept; responsible for clinical pharmacology components including PK, PK/PD, food effect (oral compound), drug-drug interaction, QTc, and immunogenicity (biologics).
Collaborate with preclinical scientists and analyze translational models developed from preclinical data to ensure adequate confidence in prediction of human PK and efficacious dose projections.
Provide scientific justification for optimal human starting dose and dose escalation schemes for first-in-human protocols based on all available preclinical information including toxicology, efficacy models, physicochemical and biochemical characterization.
Work closely with clinical assay specialists to ensure that appropriate and validated bioanalytical assays are available on time for measuring drug concentration and anti-drug antibodies (for biologics) for 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 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.) or equivalent experience in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, Engineering, Systems Biology or other related disciplines.
Proficiency in mathematical modeling and programming as demonstrated by hands-on experience in computational tools (e.g. R, NONMEM)
Demonstrated ability to work in a highly collaborative, multi-disciplinary team setting.
Excellent verbal and written communication skills.
Self-directed and highly-motivated researcher, with willingness to learning new tools and approaches.
Prior industry experience in clinical pharmacology with expertise in PK/PD modeling.
2-4 years of industry or equivalent experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics.
OTHER JOB DETAILS
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