Senior Scientist II - Modeling and Simulation

Role Summary

Senior Scientist II - Modeling and Simulation is an onsite role based out of Irvine, CA. As a member of multidisciplinary teams, this individual will contribute both Pharmacokinetic and Modeling and Simulation (M&S) expertise 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 nonclinical models and humans. 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.

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.
• Analysis of 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
• May mentor/supervise a team of one or more and guide and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.

Qualifications

• Required: Bachelor’s Degree and typically 12 years of experience OR Master’s Degree and typically 10 years of experience OR PhD and typically 4 years of experience in Pharmaceutical Sciences, Quantitative Pharmacology, Biomedical/Chemical Engineering, Pharmacometrics or related field.
• Required: 2+ years of experience in PK/PD modeling & simulation, quantitative pharmacology, and/or applied population PK in the pharmaceutical industry.
• Required: Ability to work onsite based out of our Irvine, CA location.
• Required: Academic and/or industry experience in either physiologically-based pharmacokinetic (PBPK) modeling or population PK/PKPD modeling.
• Required: Strong knowledge of biology (mechanism of action)/pharmacology, clinical immunology, protein sciences, statistics, and pharmaceutical development.
• Required: Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills to develop models.
• Required: Data manipulation and programming skills and ideally with the use of programs such as SAS, R, S+ or similar programs.
• Required: Experience using Phoenix WNL, GastroPlus, and SimCyp
• Required: Scientific publications in area of specialization.
• Required: Effective written and verbal communication skills.
• Required: Strong ability to collaborate with others.
• Required: Ability to keep up-to-date with and propose the implementation of scientific and technological developments in the area of modeling.
• Required: The successful candidate is required to have ability to work within a diverse workforce.

Skills

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

Education

• Bachelor’s Degree with corresponding experience in Pharmaceutical Sciences, Quantitative Pharmacology, Biomedical/Chemical Engineering, Pharmacometrics or related field, or higher degree as noted in Qualifications.