Senior Scientist II - Modeling and Simulation

Company Description

Abb Vie’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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

The Local Delivery Translational Sciences (LDTS) organization at Abb Vie 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, supporting all new molecular entities across multiple therapeutic areas.

The organization is responsible for defining the relationship between drug exposure (e.g., concentrations in blood/ local tissue) and efficacy and safety measures in non‑clinical models to select the optimal dose, dosing intervals, and biomarkers for FIH studies.

The organization provides critical support for conducting technical due diligence of new business opportunities (both in‑licensing and out‑licensing) by assessing probability of success for achieving the Target Product Profile (TPP). It also contributes to responses to defend our intellectual properties and extension of patent protection, provides critical support for life‑cycle management of marketed products, responds to questions from post‑marketing safety, legal, pharmaceutical manufacturing and regulatory for marketed products worldwide, and publication of scientific information in patents and manuscripts.

The Senior Scientist II - Modeling and Simulation is an onsite role based out of our Irvine, CA location.

As a member of multidisciplinary teams, this individual will contribute both Pharmacokinetic and Modeling and Simulation (M&S) expertise to lead efforts to build in‑silico drug models that describe the relationship(s) between exposure (drug, antibody, biomarker) and response (pharmacodynamic) for both desired and undesired effects. These models will support formulation development as well as early‑stage clinical development activities utilizing various sources of data from both non‑clinical models and humans.

This scientist should be comfortable with exploratory analyses and non‑conventional modeling beyond systemic drug development including ophthalmology, and aesthetics/dermatology. This scientist should be proactive, inquisitive, a self‑starter who is eager to learn and thrives in a fast pace and independent environment, with a desire to interact as a modeling and simulation expert with matrix project teams.

Specific responsibilities include:

• 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.
• Analysis of PK/PD data, both clinical and non‑clinical, through the use of 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.
• In collaboration with other stakeholders, conduct and integrate data analyses and summarize modeling outcomes to support IND, CTA, IMPD, NDA, and BLA filing and regulatory correspondences.
• 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…