BioSpace
Principal Research Scientist - Modeling and Simulation
BioSpace, Irvine, California, United States, 92713
Overview
Principal Research Scientist - Modeling and Simulation
at AbbVie. AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience, and eye care, with products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. 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 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 as appropriate to meet project deliverables. Collaborate with other stakeholders to conduct and integrate data analyses and summarize modeling outcomes to support IND, CTA, IMPD, NDA, and BLA filings and regulatory correspondences. Conduct exploratory analyses and non-conventional modeling beyond systemic drug development with a focus on locally-administered/acting products. Maintain awareness of current technologies in PK/PD and PBPK modeling. Develop close and effective 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 effective collaborations with key stakeholders at the project level 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 & simulation, quantitative pharmacology, and/or applied population PK in the pharmaceutical industry. Academic and/or industry experience in PBPK modeling or population PK/PKPD modeling. Strong knowledge of biology (mechanism of action)/pharmacology, clinical immunology, protein sciences, statistics, and pharmaceutical development. Ability to learn new areas of biological sciences and build on a solid foundation of quantitative skills to develop models. Data manipulation and programming skills with programs such as SAS, R, S+ or similar. 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 up-to-date with and propose the 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 that AbbVie believes in good faith it will pay for this role at the time of posting based on the job grade for this position. Individual compensation paid within this range will depend on factors including geographic location and may be higher or lower than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs. Note: No amount of pay is considered wages or compensation until earned, vested, and determinable. Compensation details are at the Company\'s sole discretion, subject to applicable law. 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.
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Principal Research Scientist - Modeling and Simulation
at AbbVie. AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience, and eye care, with products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. 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 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 as appropriate to meet project deliverables. Collaborate with other stakeholders to conduct and integrate data analyses and summarize modeling outcomes to support IND, CTA, IMPD, NDA, and BLA filings and regulatory correspondences. Conduct exploratory analyses and non-conventional modeling beyond systemic drug development with a focus on locally-administered/acting products. Maintain awareness of current technologies in PK/PD and PBPK modeling. Develop close and effective 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 effective collaborations with key stakeholders at the project level 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 & simulation, quantitative pharmacology, and/or applied population PK in the pharmaceutical industry. Academic and/or industry experience in PBPK modeling or population PK/PKPD modeling. Strong knowledge of biology (mechanism of action)/pharmacology, clinical immunology, protein sciences, statistics, and pharmaceutical development. Ability to learn new areas of biological sciences and build on a solid foundation of quantitative skills to develop models. Data manipulation and programming skills with programs such as SAS, R, S+ or similar. 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 up-to-date with and propose the 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 that AbbVie believes in good faith it will pay for this role at the time of posting based on the job grade for this position. Individual compensation paid within this range will depend on factors including geographic location and may be higher or lower than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs. Note: No amount of pay is considered wages or compensation until earned, vested, and determinable. Compensation details are at the Company\'s sole discretion, subject to applicable law. 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.
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