Principal Research Scientist - Modeling and Simulation

Role Summary

Principal Research Scientist – Modeling and Simulation is an onsite role based out of Irvine, CA. The role contributes pharmacokinetic and modeling and simulation expertise to build in silico drug models describing exposure–response relationships to support formulation development and early-stage clinical development, across non-clinical models and humans. The role involves exploratory analyses and non-conventional modeling, with a focus on ophthalmology and aesthetics/dermatology, in a fast-paced, independent environment.

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, clinical and nonclinical, using advanced modeling to support dose selection, study design, and proof-of-concept.
• Identify and monitor vendors/consultants or engage internal resources to meet project deliverables.
• Collaborate with stakeholders to conduct and integrate data analyses and summarize modeling outcomes to support IND, CTA, IMPD, NDA, and BLA filings and regulatory communications.
• Engage in 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 partnerships with nonclinical/clinical pharmacology/PKPD, biomarker scientists, safety scientists, researchers, clinicians, and project teams.
• Design and oversee preclinical PK/TK studies.
• Establish collaborations 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 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 quantitative skills to develop models
• Data manipulation and programming skills 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 collaboration skills
• Ability to stay up-to-date with scientific and technological developments in modeling
• Ability to work within a diverse workforce

Preferred Experience

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