Hispanic Alliance for Career Enhancement
Principal Research Scientist - Modeling and Simulation
Hispanic Alliance for Career Enhancement, Irvine, California, United States, 92713
Overview
AbbVie's Local Delivery Translational Sciences (LDTS) organization leads the strategy, generation, analyses, interpretations, and reporting of non-clinical data and communications with global regulatory agencies in Translational Pharmacology, Non-clinical Pharmacokinetics, Exposure-Response, Immunogenicity, and Biopharmaceutics. The LDTS supports all phases of non-clinical development across multiple therapeutic areas and products. The LDTS defines the relationship between drug exposure and efficacy/safety in non-clinical models to select optimal dose, dosing intervals, and biomarkers for first-in-human studies. The organization also contributes to due diligence for new business opportunities, responds to regulatory questions, supports life-cycle management of marketed products, and contributes to publishing scientific information in patents and manuscripts. The LDTS group at AbbVie seeks a Principal Research Scientist – Modeling and Simulation. This role contributes pharmacokinetic and modeling and simulation (M&S) expertise to build in silico drug models describing exposure and response for both desired and undesired effects. Models will support formulation development and early-stage clinical activities, using data from non-clinical models and humans. The role includes exploratory analyses and non-conventional modeling beyond systemic drug development, including ophthalmology, neurotoxin, and aesthetics/dermatology. The scientist should be proactive, inquisitive, a self-starter who thrives in a fast-paced, independent environment and collaborates with matrix project teams as a modeling and simulation expert. Responsibilities
Apply PK and PK/PD modeling/simulation to guide the design and execution of in vivo preclinical animal experiments and/or early-stage clinical trials. Identify opportunities to apply and develop modeling and simulation strategies across the R&D portfolio, with a focus on ophthalmology, neurotoxin, and aesthetics/dermatology. Integrate M&S knowledge to contribute to optimizing translational sciences strategies. Analyze PK/PD data, both clinical and nonclinical, using sophisticated mathematical and statistical modeling and simulation tools to support dose selection, study design, and proof-of-concept. Identify and monitor vendors and consultants or engage internal resources to meet project deliverables. Collaborate with stakeholders to conduct and integrate data analyses and summarize modeling outcomes to support IND, CTA, IMPD, NDA, and BLA filings and regulatory correspondences. Perform exploratory analyses and non-conventional modeling with a focus on locally administered/acting products. Maintain awareness of current technologies in PK/PD and PBPK modeling. Develop partnerships with other nonclinical and clinical pharmacology/PKPD and biomarker scientists, safety scientists, research scientists, clinicians, and project teams. Design and provide scientific oversight of preclinical PK/TK studies. Establish and maintain collaborations to facilitate data integration for biomarker selection, candidate nomination/selection, and human dose prediction. Qualifications
BS with typically 14+ years of experience OR MS with typically 12+ years of experience OR PhD with typically 6+ years of experience in Pharmaceutical Sciences, Quantitative Pharmacology, Biomedical/Chemical Engineering, Pharmacometrics or related field. 2+ years of experience in PK/PD modeling and simulation, quantitative pharmacology, and/or applied population PK in the pharmaceutical industry. Academic and/or industry experience in physiologically-based pharmacokinetic (PBPK) modeling or population PK/PKPD modeling. Strong knowledge of biology (mechanism of action) and pharmacology, toxicology, clinical immunology, protein sciences, statistics, and pharmaceutical development. Ability to learn new areas of biological sciences and build on quantitative skills to develop models. Data manipulation and programming skills, ideally with SAS, R, S-Plus or similar programs. Experience using Phoenix WNL, GastroPlus, and SimCyp. Scientific publications in area of specialization. Effective written and verbal communication skills. Strong ability to collaborate with others. Ability to stay current with and propose implementation of scientific and technological developments in modeling. Ability to work within a diverse workforce. Preferred Experience
Experience with biologics including gene therapy. Experience with general programming and data analysis tools/languages such as R, Matlab, Berkeley Madonna, ADAPT, etc. Additional Information
The compensation range described below is the range of possible base pay compensation the Company believes in good faith it will pay for this role at the time of posting, based on the job grade. Individual compensation will depend on factors including geographic location and may be modified in the future. We offer a comprehensive benefits package including paid time off, medical/dental/vision, and 401(k) to eligible employees. This job is eligible to participate in short-term and long-term incentive programs. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit the following information about equal employment opportunity and reasonable accommodations: We encourage applicants to review AbbVie’s equal employment opportunity statement and reasonable accommodations pages.
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AbbVie's Local Delivery Translational Sciences (LDTS) organization leads the strategy, generation, analyses, interpretations, and reporting of non-clinical data and communications with global regulatory agencies in Translational Pharmacology, Non-clinical Pharmacokinetics, Exposure-Response, Immunogenicity, and Biopharmaceutics. The LDTS supports all phases of non-clinical development across multiple therapeutic areas and products. The LDTS defines the relationship between drug exposure and efficacy/safety in non-clinical models to select optimal dose, dosing intervals, and biomarkers for first-in-human studies. The organization also contributes to due diligence for new business opportunities, responds to regulatory questions, supports life-cycle management of marketed products, and contributes to publishing scientific information in patents and manuscripts. The LDTS group at AbbVie seeks a Principal Research Scientist – Modeling and Simulation. This role contributes pharmacokinetic and modeling and simulation (M&S) expertise to build in silico drug models describing exposure and response for both desired and undesired effects. Models will support formulation development and early-stage clinical activities, using data from non-clinical models and humans. The role includes exploratory analyses and non-conventional modeling beyond systemic drug development, including ophthalmology, neurotoxin, and aesthetics/dermatology. The scientist should be proactive, inquisitive, a self-starter who thrives in a fast-paced, independent environment and collaborates with matrix project teams as a modeling and simulation expert. Responsibilities
Apply PK and PK/PD modeling/simulation to guide the design and execution of in vivo preclinical animal experiments and/or early-stage clinical trials. Identify opportunities to apply and develop modeling and simulation strategies across the R&D portfolio, with a focus on ophthalmology, neurotoxin, and aesthetics/dermatology. Integrate M&S knowledge to contribute to optimizing translational sciences strategies. Analyze PK/PD data, both clinical and nonclinical, using sophisticated mathematical and statistical modeling and simulation tools to support dose selection, study design, and proof-of-concept. Identify and monitor vendors and consultants or engage internal resources to meet project deliverables. Collaborate with stakeholders to conduct and integrate data analyses and summarize modeling outcomes to support IND, CTA, IMPD, NDA, and BLA filings and regulatory correspondences. Perform exploratory analyses and non-conventional modeling with a focus on locally administered/acting products. Maintain awareness of current technologies in PK/PD and PBPK modeling. Develop partnerships with other nonclinical and clinical pharmacology/PKPD and biomarker scientists, safety scientists, research scientists, clinicians, and project teams. Design and provide scientific oversight of preclinical PK/TK studies. Establish and maintain collaborations to facilitate data integration for biomarker selection, candidate nomination/selection, and human dose prediction. Qualifications
BS with typically 14+ years of experience OR MS with typically 12+ years of experience OR PhD with typically 6+ years of experience in Pharmaceutical Sciences, Quantitative Pharmacology, Biomedical/Chemical Engineering, Pharmacometrics or related field. 2+ years of experience in PK/PD modeling and simulation, quantitative pharmacology, and/or applied population PK in the pharmaceutical industry. Academic and/or industry experience in physiologically-based pharmacokinetic (PBPK) modeling or population PK/PKPD modeling. Strong knowledge of biology (mechanism of action) and pharmacology, toxicology, clinical immunology, protein sciences, statistics, and pharmaceutical development. Ability to learn new areas of biological sciences and build on quantitative skills to develop models. Data manipulation and programming skills, ideally with SAS, R, S-Plus or similar programs. Experience using Phoenix WNL, GastroPlus, and SimCyp. Scientific publications in area of specialization. Effective written and verbal communication skills. Strong ability to collaborate with others. Ability to stay current with and propose implementation of scientific and technological developments in modeling. Ability to work within a diverse workforce. Preferred Experience
Experience with biologics including gene therapy. Experience with general programming and data analysis tools/languages such as R, Matlab, Berkeley Madonna, ADAPT, etc. Additional Information
The compensation range described below is the range of possible base pay compensation the Company believes in good faith it will pay for this role at the time of posting, based on the job grade. Individual compensation will depend on factors including geographic location and may be modified in the future. We offer a comprehensive benefits package including paid time off, medical/dental/vision, and 401(k) to eligible employees. This job is eligible to participate in short-term and long-term incentive programs. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit the following information about equal employment opportunity and reasonable accommodations: We encourage applicants to review AbbVie’s equal employment opportunity statement and reasonable accommodations pages.
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