Summarize the primary purpose & key accountabilities of the job.
- Implements model informed drug development (MIDD) plans across projects and disease areas in order to optimize prospective studies, inform drug development strategy and project decision-making, in collaboration with partners.
- Conducts and reports quantitative analyses which integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics, and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development.
- Identifies opportunities where modeling and simulation can advance the understanding of pharmacological activity, efficacy and safety.
- May help in providing support and/or development of quantitative methodology, pharmacometrics tools, software, hardware, and related business processes
Indicate the primary responsibilities critical to the job.
QUALIFICATIONS / SKILLS
- Responsible for the planning and execution of relevant quantitative analyses which may include population pharmacokinetics, pharmacokinetics/pharmacodynamics, exposure response, disease progression modeling, model-based meta analysis, quantitative knowledge management, decision analysis, and EQDD strategy in collaboration with partners.
- Prepares formal presentations and written reports to Pfizer standards.
- Provide Quantitative Clinical Pharmacology expertise on multidisciplinary development teams, working closely with clinical pharmacologists, clinicians and statisticians to create clinical development plans that include assessments of a drug's efficacy, safety, and commercial viability.
- May contributes with project teams/partners to regulatory documents.
- Stays abreast of literature, government guidelines, and internal guidance as relates to pharmacometrics and MIDD, including internal SOPs and regulations in order to be a team resource of pharmacometric knowledge and applications.
- Contribute to the development or improvement of our tools, processes and methodology, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia and academic relationships.
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
- PhD, DSc, PharmD, DPhi, D.Eng, D.E.Sc, or MD with strong quantitative skills (e.g., pharmacometrics, pharmacokinetics, mechanistic modeling/systems pharmacology, literature meta-analyses, clinical trial simulations, statistics).
- Experience using R software
- Good communication skills (written, oral presentation)
- 0 to 4 years experience in the quantitative field
- Other pharmacometric software experience (e.g. Nonmem, PsN, MATLAB)
- Other statistical software experience (e.g. Stan)
- Other programming experience (e.g. Python, C++)
- We encourage applicants from different disciplines including clinical pharmacology, engineering, biostatistics, medicine, biology, etc.
Candidates with significant experience are also sought. In addition to professional challenge, we offer a culture that supports and encourages ideas, and recognizes individual contribution.ORGANIZATIONAL RELATIONSHIPS
Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.
Reports to Pharmacometrics Group Leader within the line organization of Pharmacometrics, GPD-Clinical Pharmacology
Matrixed relationships particularly with Clinical Pharmacology Leads, Clinicians, Statisticians, and colleagues from Programming groups and other groups as requiredRESOURCES MANAGED
Summary of resources managed.
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