Principal Research Scientist - Modeling and Simulation

Role Summary

The Principal Research Scientist – Modeling and Simulation is an onsite role based in Irvine, CA. The role contributes pharmacokinetic (PK) and modeling & simulation (M&S) expertise to build in silico models describing exposure–response relationships to inform formulation development and early-stage clinical programs. The position supports non-clinical and translational activities, working across ophthalmology and aesthetics/dermatology, and collaborates with matrix project teams in a fast-paced 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, both clinical and nonclinical, using advanced 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.
• Conduct 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 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.
• Establish and maintain collaborations with key stakeholders to facilitate data integration for biomarker selection, candidate nomination/selection, and human dose prediction.

Qualifications

• Required: 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 a related field.
• Required: 2+ years of experience in PK/PD modeling & simulation, quantitative pharmacology, and/or applied population PK in the pharmaceutical industry.
• Required: Academic and/or industry experience in either physiologically-based pharmacokinetic (PBPK) modeling or population PK/PKPD modeling.
• Required: Strong knowledge of biology (MOA)/pharmacology, clinical immunology, protein sciences, statistics, and pharmaceutical development.
• Required: Ability to learn new areas of biological sciences and build on a solid foundation of quantitative skills to develop models.
• Required: Data manipulation and programming skills, ideally with SAS, R, S+, or similar programs.
• Required: Experience using Phoenix, WNL, GastroPlus, and SimCyp.
• Required: Scientific publications in the area of specialization.
• Required: Effective written and verbal communication skills.
• Required: Strong ability to collaborate with others.
• Required: Ability to stay up-to-date with and propose the implementation of scientific and technological developments in modeling.
• Required: Ability to work within a diverse workforce.
• Preferred: Experience with biologics including gene therapy.
• Preferred: Experience with general programming and data analysis tools/languages such as R, Matlab, Berkeley Madonna, ADAPT, etc.