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 filings and regulatory correspondences. - Explore and apply 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.

Requirements

- 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 foundation of quantitative skills to develop models. - 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. - Ability to keep up-to-date with and propose the implementation of scientific and technological developments in the area of modeling. - The successful candidate is required to have ability to work within a diverse workforce.

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 foundation of quantitative skills to develop models. - 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. - Ability to keep up-to-date with and propose the implementation of scientific and technological developments in the area of modeling. - The successful candidate is required to have ability to work within a diverse workforce.

Skills

- PK/PD modeling & simulation, quantitative pharmacology, and/or applied population PK. - Physiologically-based pharmacokinetic (PBPK) modeling or population PK/PKPD modeling. - Biology/mechanism of action/pharmacology, clinical immunology, protein sciences, statistics, and pharmaceutical development. - Data manipulation and programming skills (SAS, R, S+). - Experience with 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 the implementation of scientific and technological developments in the area of modeling.

Benefits

- Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k). - Participation in short-term and long-term incentive programs.

Pay

- Compensation range TBD.