BioSpace
Principal Research Scientist - Modeling and Simulation
BioSpace, Irvine, California, United States, 92713
Principal Research Scientist - Modeling and Simulation
Lead efforts to build in silico drug models that describe the relationship between exposure and response for both desired and undesired effects, supporting formulation development and early‑stage clinical development. Provide pharmacokinetic and modeling and simulation expertise within multidisciplinary teams, focusing on ophthalmology, aesthetics, and dermatology.
Responsibilities
Apply PK and PK/PD modeling/simulation to guide the design and execution of in vivo preclinical animal experiments and 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 optimize translational science strategies.
Analyze PK/PD data, both clinical and nonclinical, through sophisticated mathematical and statistical modeling and simulation tools for dose selection, study design, and proof‑of‑concept.
Identify and monitor vendors/consultants or engage internal resources to meet project deliverables.
Collaborate with stakeholders to conduct and integrate data analyses, summarize modeling outcomes, and support regulatory filings (IND, CTA, IMPD, NDA, BLA).
Conduct exploratory analyses and non‑conventional modeling beyond systemic drug development for locally‑administered/acting products.
Maintain awareness of current technologies in PK/PD and PBPK modeling.
Develop close partnerships with nonclinical and clinical pharmacology/PKPD, biomarker scientists, safety scientists, and project teams.
Provide scientific oversight preclinical PK/TK studies.
At project level, collaborate with key stakeholders to facilitate data integration for biomarker selection, candidate nomination/selection, and human dose prediction.
Qualifications
BS with 14+ years of experience, or MS with 12+ years, or PhD with 6+ years in Pharmaceutical Sciences, Quantitative Pharmacology, Biomedical/Chemical Engineering, Pharmacometrics, or related field.
2+ years of experience in PK/PD modeling & simulation, quantitative pharmacology, or applied population PK in the pharmaceutical industry.
Experience in physiologically‑based pharmacokinetic (PBPK) modeling or population PK/PKPD modeling.
Strong knowledge of biology, pharmacology, clinical immunology, protein sciences, statistics, and pharmaceutical development.
Proficiency in data manipulation and programming, ideally with SAS, R, S+, or similar.
Experience with Phoenix WNL, GastroPlus, and SimCyp.
Scientific publications in relevant area of specialization.
Excellent written and verbal communication skills and strong collaboration ability.
Ability to stay up‑to‑date with scientific and technological developments in modeling.
Ability to work within a diverse workforce.
Preferred Experience
Experience with biologics including gene therapy.
Experience with programming and data analysis tools/languages such as R, Matlab, Berkeley Madonna, ADAPT, etc.
The compensation range described below is the range of possible base pay compensation that the company believes in good faith will pay for this role at the time of posting based on the job grade. Pay may vary by location and may be modified in the future. The company offers a comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees, as well as eligibility for 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.
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Responsibilities
Apply PK and PK/PD modeling/simulation to guide the design and execution of in vivo preclinical animal experiments and 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 optimize translational science strategies.
Analyze PK/PD data, both clinical and nonclinical, through sophisticated mathematical and statistical modeling and simulation tools for dose selection, study design, and proof‑of‑concept.
Identify and monitor vendors/consultants or engage internal resources to meet project deliverables.
Collaborate with stakeholders to conduct and integrate data analyses, summarize modeling outcomes, and support regulatory filings (IND, CTA, IMPD, NDA, BLA).
Conduct exploratory analyses and non‑conventional modeling beyond systemic drug development for locally‑administered/acting products.
Maintain awareness of current technologies in PK/PD and PBPK modeling.
Develop close partnerships with nonclinical and clinical pharmacology/PKPD, biomarker scientists, safety scientists, and project teams.
Provide scientific oversight preclinical PK/TK studies.
At project level, collaborate with key stakeholders to facilitate data integration for biomarker selection, candidate nomination/selection, and human dose prediction.
Qualifications
BS with 14+ years of experience, or MS with 12+ years, or PhD with 6+ years in Pharmaceutical Sciences, Quantitative Pharmacology, Biomedical/Chemical Engineering, Pharmacometrics, or related field.
2+ years of experience in PK/PD modeling & simulation, quantitative pharmacology, or applied population PK in the pharmaceutical industry.
Experience in physiologically‑based pharmacokinetic (PBPK) modeling or population PK/PKPD modeling.
Strong knowledge of biology, pharmacology, clinical immunology, protein sciences, statistics, and pharmaceutical development.
Proficiency in data manipulation and programming, ideally with SAS, R, S+, or similar.
Experience with Phoenix WNL, GastroPlus, and SimCyp.
Scientific publications in relevant area of specialization.
Excellent written and verbal communication skills and strong collaboration ability.
Ability to stay up‑to‑date with scientific and technological developments in modeling.
Ability to work within a diverse workforce.
Preferred Experience
Experience with biologics including gene therapy.
Experience with programming and data analysis tools/languages such as R, Matlab, Berkeley Madonna, ADAPT, etc.
The compensation range described below is the range of possible base pay compensation that the company believes in good faith will pay for this role at the time of posting based on the job grade. Pay may vary by location and may be modified in the future. The company offers a comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees, as well as eligibility for 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.
#J-18808-Ljbffr