Principal Research Scientist - Modeling and Simulation

About the role

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, supporting all new molecular entities across multiple therapeutic areas.

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, 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 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.
• 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.
• Data manipulation and programming skills and ideally with the use of programs such as SAS, R, S+ or similar programs.
• 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.
• Able to keep up-to-date with and propose the implementation of scientific and technological developments in the area of modeling.

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

Note: No amount of pay is considered to be 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 remains 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.