• JOB SUMMARY
  • With guidance, contribute to the development of the model informed drug development (MIDD) plans for an assigned project to optimize prospective studies, inform drug development strategy and project decision-making, in collaboration with partners, in particular, clinical pharmacology
  • Conduct and report quantitative analyses which integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics, and disease states to optimize dosing regimens, risk-benefit profiles, and study designs throughout all phases (first-in-human through post-approval) of clinical drug development.
  • With guidance, identify opportunities where MIDD approaches can advance the understanding of pharmacological activity, efficacy and safety, including dose selection and optimization.
  • Provide support in the development and application of state-of-the-art quantitative methodologies, pharmacometrics tools, software, hardware, and/or related business processes.
  • Oncology is the primary therapeutic area for development projects for this role, with potential to work in additional therapeutic areas and projects spanning multiple therapeutic areas.

ROLE RESPONSIBILITIES

• With guidance, provide MIDD expertise on multidisciplinary development teams, working closely with clinical pharmacologists, clinicians, and statisticians, and other scientists to create MIDD plans that include assessments of a drug's efficacy, safety, and commercial viability.
• Responsible for the execution of relevant quantitative analyses which may include population pharmacokinetics, pharmacokinetics/pharmacodynamics, exposure response, disease progression modeling, model-based meta-analysis, quantitative knowledge management, and decision analysis for multiple analyses supporting a program.
• Clearly communicate modeling and simulation results to technical and non-technical audiences internally and externally
• Prepare formal presentations and written reports to Pfizer standards.
• Author, contribute, and perform technical quality control checks for regulatory documents (modeling reports, summary documents, briefing books, regulatory responses).
• Stay abreast of literature, regulatory 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.
• May train, develop, and mentor less experienced pharmacometricians or other colleagues in systems pharmacology, clinical pharmacology or translational clinical sciences.
• Contribute to pharmacometrics' ability to act as a conduit for cross learnings within/across the clinical development organizations. Promote, educate, and mentor others in application of quantitative techniques, best practices, MIDD, and share experiences through appropriate local and global discussions.

• Qualifications include PhD, PharmD, or equivalent, including expertise in one or more areas (e.g., pharmacometrics, clinical pharmacology, pharmacokinetics, pharmaceutical sciences, biostatistics, applied mathematics, or related discipline).
• Up to 4 years of experience in the relevant quantitative field.
• Strong scientific and quantitative analysis with good working knowledge of pharmacokinetics, pharmacology, pharmaceutics, and/or statistics. Experience in population PK, PK/PD, mechanistic/systems pharmacology or exposure-response modeling and simulation is particularly relevant.
• Basic understanding/knowledge of pharmacology, biology, physiology/pathophysiology (particularly in oncology), and drug research & development process
• Strong communication skills including written, verbal and presentation.
• Candidates from alternative backgrounds (e.g., mathematics, engineering, system biology, medicine) will be considered if they can demonstrate relevant experience and expertise.

• Industry or regulatory experience in pharmacometrics, clinical PK/PD, clinical pharmacology, or systems pharmacology.
• Experience using R, NONMEM, and PsN software.
• Experience in oncology therapeutic area, including general familiarity with clinical disease types and sub-types, understanding of different treatment modalities (e.g., cytotoxic agents, immunotherapy, antibody-drug conjugates, etc.) and common modeling approaches (e.g., tumor dynamic modeling, myelosuppression modeling, survival analysis, etc.)
• Other relevant software experience (e.g., mrgsolve, LaTeX, Rmarkdown, nlmixr2)
• Experience in clinical trial simulation, machine learning, biostatistics, Bayesian methods, or literature meta-analyses/model-based meta-analyses
• Candidates with significant (3-5) experience will also be considered. Position role and title (e.g. Associate Director) will be commensurate with type and years of experience.

• Reports to Oncology Pharmacometrics Group Leader within the line organization of Pharmacometrics, PRD-Translational Clinical Sciences
• Matrixed relationships particularly with clinical pharmacology leads, clinicians, statisticians, colleagues from programming groups and other groups as required

• Sitting, ability to perform complex data analyses