Senior Scientist, Pharmacometrics Resume

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Senior Scientist, Pharmacometrics Resume Mia York Senior Scientist, Pharmacometrics (608) 555-4187 mia.york@example.com linkedin.com/example/miayork Madison, WI 53705 STRENGTHS Dose selection judgment Simulation results became clear regimen options for clinicians and program leaders, with practical tradeoffs made visible. Reproducible modeling NONMEM and R workflows kept assumptions, diagnostics, and evidence traceable. Colleagues knew where to find answers. Regulatory writing Reports and agency responses connected conclusions with source analyses, helping reviewers follow each scientific decision. Cross functional work Data managers, statisticians, and clinical teams received useful analysis inputs early, which kept deliverables moving. Scientific mentoring Junior scientists gained practical guidance on diagnostics and documentation. Questions became easier to solve together. SKILLS Population PK PK/PD Modeling Exposure Response NONMEM Monolix R Clinical Pharmacology Clinical Trials Data Management Dose Selection Analysis Plans Regulatory Writing Quality Control Software Validation Scientific Research LANGUAGES English Native 40 Spanish Intermediate 20 MY CAREER 9 Years Senior Scientist, Pharmacometrics at Northstar Biopharma (3.2 Years) Scientist II, Clinical Pharmacometrics at Lakefront Therapeutics (2 Years) Scientist, Clinical Pharmacology Modeling at Prairie Ridge Pharmaceuticals (1.8 Years) Pharmacometrics Research Fellow at Midwest University Medical Center (2 Years) SUMMARY Senior pharmacometrics scientist with seven years supporting clinical development through population PK , PK/PD, and exposure response modeling across early and late stage programs. PhD trained in pharmaceutical sciences with hands on expertise in NONMEM, Monolix, R, model informed drug development , clinical trial design, dose regimen evaluation, and regulatory documentation. Converts longitudinal clinical data into clear recommendations for dose selection, study design, and development strategy. Authors analysis plans, pharmacometrics reports, submission materials, and agency responses within SOP controlled environments. Partners closely with clinical pharmacology, statistics, data management, and clinical operations teams, while mentoring junior scientists and improving reproducible workflows. Brings practical scientific judgment, careful quality control , and clear communication that can support sound decisions across clinical programs. EXPERIENCE Senior Scientist, Pharmacometrics Northstar Biopharma July 2023 - Present Cambridge, MA Leads population PK, exposure response, and model informed development work across three clinical stage programs. Owns analysis planning, simulation evidence, regulatory documentation, quality control, and mentoring within matrix teams. Led population PK analyses integrating concentration, efficacy, safety, and covariate data for dose discussions. Built NONMEM and R workflows with diagnostics and visual predictive checks for reproducible review packages. Authored analysis plans defining datasets, assumptions, sensitivity analyses, QC expectations, and interpretation standards. Translated simulation results into dose selection options for clinicians, statisticians, and program leaders. Supported regulatory modules and agency responses by tracing conclusions to source analyses and technical reviews. Mentored junior scientists on model diagnostics, documentation, software validation , and controlled workflow improvements. Scientist II, Clinical Pharmacometrics Lakefront Therapeutics June 2021 - June 2023 Chicago, IL Executed population PK and PK/PD analyses for small molecule programs, connecting modeling outputs with study planning and regulatory communication. Coordinated traceable datasets, QC, reports, and scientific presentations across development partners. Executed population PK and PK / PD analyses with NONMEM, Monolix, and R for small molecule programs. Developed dosing simulations that informed clinical study planning and special population questions. Defined data requirements with clinical data management and biostatistics partners before model execution. Performed independent QC of models, scripts, tables, figures, and reports against study timelines. Drafted clinical pharmacology report sections and analyses for regulatory briefing materials and written responses. Presented diagnostics and limitations at project meetings and coauthored a peer reviewed PK/PD manuscript. Scientist, Clinical Pharmacology Modeling Prairie Ridge Pharmaceuticals August 2019 - May 2021 Indianapolis, IN Supported Phase I and Phase II pharmacometric analyses under senior scientific oversight, preparing datasets, models, simulations, and reports that strengthened dose and study design decisions. Prepared modeling datasets, exploratory graphics, base models, and covariate assessments for Phase I and II studies. Applied R and NONMEM to evaluate concentration time data and exposure relationships with reproducible records. Generated simulations comparing candidate regimens for escalation, sampling, and subsequent study design discussions. Reconciled dosing, sampling, demographic, and laboratory records with programmers and data managers. Prepared tables, figures, and report text linking objectives, methods, results, and development conclusions. Contributed posters and presentations while following SOPs , peer review procedures, and regulatory documentation expectations. Pharmacometrics Research Fellow Midwest University Medical Center July 2017 - July 2019 Milwaukee, WI Conducted supervised population PK research using clinical and simulated datasets, developing models, simulations, quality control routines, and scientific communications for therapeutic development studies. Conducted supervised population PK research investigating variability and dose exposure relationships in clinical studies. Created NONMEM models and R diagnostics comparing structural and statistical assumptions through goodness of fit assessments. Designed simulation experiments testing dosing questions for faculty investigators and clinical research collaborators. Established data cleaning and QC routines for dosing, concentration, and covariate records. Prepared methods, results, figures, and technical appendices for abstracts and manuscripts. Presented research at scientific meetings and supported trainees with introductory modeling and reproducible R practices. PROJECTS Clinical Dose Selection Simulation Program 2024 Built a cross functional simulation package that compared candidate dose regimens, summarized exposure response evidence, and supported practical clinical development discussions. Regulatory Pharmacometric Evidence Package 2023 Connected model assumptions, diagnostics, sensitivity analyses, and interpretation into a traceable package for regulatory documentation and internal decision review. LEADERSHIP & AWARDS Recognized for translating complex pharmacometric findings into clear dose selection recommendations for development teams. Selected as a scientific contributor for peer reviewed PK and PD research communications and regulatory support. Trusted mentor for junior scientists learning model diagnostics, reproducible R workflows, and controlled documentation. EDUCATION Ph.D. in Pharmaceutical Sciences University of Wisconsin Madison GPA: 4.0 2017 Madison, WI Coursework: Pharmacometrics, pharmacokinetics, pharmacodynamics, clinical pharmacology Bachelor's Degree in Biological Sciences Marquette University GPA: 3.8 2012 Milwaukee, WI Coursework: Biology, pharmacology, biochemistry, biological research CERTIFICATIONS Good Clinical Practice Training, CITI Program 2026 Pharmacometric Modeling and Simulation Certificate 2024 TECHNICAL SKILLS Pharmacometrics Software: NONMEM, Monolix, R Modeling Methods: Population PK, PK/PD modeling, exposure response modeling Simulation Methods: Visual predictive checks, dose simulations, sensitivity analysis Clinical Data: Concentration data, efficacy data, safety data Data Preparation: Analysis datasets, covariate records, data cleaning Study Development: Clinical trial design, dose regimen selection, sampling schedules Regulatory Documents: Pharmacometric reports, agency responses, submission modules Quality Systems: Quality control, software validation, SOP compliance Scientific Communication: Scientific presentations, manuscripts, peer review Research Outputs: Tables, figures, technical appendices SKILLS Population PK PK/PD Modeling Exposure Response NONMEM Monolix R Clinical Pharmacology Clinical Trials Data Management Dose Selection Analysis Plans Regulatory Writing Quality Control Software Validation Scientific Research PROFESSIONAL AFFILIATIONS Collaborated with clinical pharmacology, biostatistics, data management, and clinical operations colleagues across matrix programs. Shared pharmacometric methods through scientific meetings, internal presentations, manuscripts, and professional research networks. LANGUAGES English (Native) Spanish (Intermediate) ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. REFERENCES AVAILABLE ON REQUEST

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