• 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.

BASIC QUALIFICATIONS

• 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.

PREFERRED QUALIFICATIONS

• 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.  

ORGANIZATIONAL RELATIONSHIPS

• 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

PHYSICAL/MENTAL REQUIREMENTS

• Sitting, ability to perform complex data analyses

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to travel for business as necessary; ability to be available for business meetings in the Pacific Time Zone.

Relocation support available

Work Location Assignment: Hybrid

The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

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