Principal Research Scientist - Modeling and Simulation

Company Overview

Abb Vie’s mission is to discover and deliver innovative medicines and solutions that address serious health issues today and the challenges of tomorrow. The company focuses on immunology, oncology, neuroscience, eye care, and products and services in the Allergan Aesthetics portfolio.

Location:

Irvine, CA (on‑site)

The Local Delivery Translational Sciences (LDTS) organization leads strategy, generation, analysis, interpretation and reporting of non‑clinical data and communication with global regulatory agencies across translational pharmacology, non‑clinical PK, exposure‑response, immunogenicity, and biopharmaceutics. The role supports all phases of non‑clinical development for new molecular entities and defines the relationship between drug exposure and efficacy/safety to select optimal dose and biomarkers for first‑in‑human studies.

• Apply PK and PK/PD modeling and simulation to guide design 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 sciences strategies.
• Analyze PK/PD data, both clinical and nonclinical, using mathematical and statistical modeling 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 stakeholders to conduct and integrate data analyses and summarize modeling outcomes to support regulatory filings (IND, CTA, IMPD, NDA, BLA) and correspondence.
• Perform exploratory and non‑conventional modeling beyond systemic drug development, focusing on locally‑administered products.
• Maintain awareness of current technologies in PK/PD and PBPK modeling.
• Develop close partnerships with non‑clinical and clinical pharmacology, biomarker, safety, research scientists, and project teams.
• Design and provide scientific oversight of preclinical PK/TK studies.
• Collaborate with key stakeholders to facilitate data integration for biomarker selection, candidate nomination, and human dose prediction.

• BS (14+ years experience) OR MS (12+ years) OR PhD (6+ years) 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 PBPK modeling or population PK/PD modeling.
• Strong knowledge of biology (mechanism of action)/pharmacology, clinical immunology, protein sciences, statistics, and pharmaceutical development.
• Ability to learn new biological sciences and apply quantitative skills to develop models.
• Data manipulation and programming skills, ideally using SAS, R, S+, or similar.
• Experience using Phoenix WNL, Gastro Plus, and Sim Cyp.
• Scientific publications in area of specialization.
• Effective written and verbal communication skills.
• Strong collaboration ability.
• Ability to keep up‑to‑date with and propose scientific and technological developments in modeling.
• Proficiency in working within a diverse workforce.

• Experience with biologics including gene therapy.
• Experience with general programming and data analysis tools/languages such as R, Matlab, Berkeley Madonna, ADAPT, etc.

• Base pay range: [Range] – subject to geographic location and company discretion.
• Comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
• Eligibility for short‑term and long‑term incentive programs.

Abb Vie 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 applicants seeking a reasonable accommodation: