Job Description
The Local Delivery Translational Sciences (LDTS) organization at AbbVie leads the strategy, generation, analyses, interpretations, and reporting of non‑clinical data and communications/agreements with global regulatory agencies in the areas of Translational Pharmacology, Non‑clinical Pharmacokinetics, Exposure‑Response, Immunogenicity, and Biopharmaceutics. The organization supports all phases of non‑clinical development for new molecular entities across multiple therapeutic areas, defining the relationship between drug exposure and efficacy and safety measures to select the optimal dose, dosing intervals, and biomarkers for first‑in‑human studies.
The organization provides critical support for conducting technical due diligence of new business opportunities, defending intellectual property, extending patent protection, managing life‑cycle of marketed products, responding to post‑marketing safety and regulatory queries, and publishing scientific information in patents and manuscripts.
The Principal Research Scientist – Modeling and Simulation is an onsite role based out of our Irvine, CA location.
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 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 stakeholders to conduct data analyses, summarize modeling outcomes, and support IND, CTA, IMPD, NDA, and BLA filing and regulatory correspondence.
* Perform 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 non‑clinical 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.
* At project level, establish and maintain effective collaborations with key stakeholders 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 either physiologically‑based pharmacokinetic (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 solid quantitative skills to develop models.
* Data manipulation and programming skills, preferably with 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 keep up‑to‑date with and propose implementation of scientific and technological developments in modeling.
* The successful candidate is required to have 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 the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
* We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
* This job is eligible to participate in our short‑term incentive programs.
* This job is eligible to participate in our long‑term incentive programs.
Note: No amount of pay is considered wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remain in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with 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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