Senior Scientist II - Modeling and Simulation

Role Summary

The Senior Scientist II - Modeling and Simulation is an onsite role based out of our Irvine, CA location. As a member of multidisciplinary teams, this individual will contribute both Pharmacokinetic and Modeling and Simulation (M&S) expertise to lead efforts to build in silico drug models that describe the relationship(s) between exposure and response for both desired and undesired effects. These models will support formulation development as well as early-stage clinical development activities utilizing data from nonclinical models and humans. The role involves exploratory analyses and non-conventional modeling beyond systemic drug development, with focus on ophthalmology and aesthetics/dermatology. The candidate should be proactive, inquisitive, a self-starter, and thrive in a fast-paced, independent environment, engaging 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, focusing 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 mathematical and statistical 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.
• Perform 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 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 collaborations to facilitate data integration for biomarker selection, candidate nomination/selection, and human dose prediction.
• May mentor/supervise a team and be accountable for the performance of team members.

Qualifications

• Bachelor‚Äôs Degree and typically 12 years of experience OR Master‚Äôs 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.
• 2+ years of experience in PK/PD modeling & simulation, quantitative pharmacology, and/or applied population PK in the pharmaceutical industry.
• Ability to work onsite in Irvine, CA.
• Academic and/or industry experience in PBPK modeling or population PK/PKPD modeling.
• Strong knowledge of biology (MOA)/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 current with scientific and technological developments in modeling.
• Ability to work in a diverse workforce.

Skills

• Pharmacokinetic/pharmacodynamic modeling
• Population PK/PKPD analysis
• PBPK modeling
• Data analysis and statistical modeling
• Programming with SAS, R, S+ or similar
• Model development and interpretation for translational science
• Cross-functional collaboration
• Scientific communication and documentation

Education

• As listed in Qualifications: advanced degree depending on experience (Bachelor‚Äôs, Master‚Äôs, or PhD) in relevant fields.

Additional Requirements

• Ability to work onsite in Irvine, CA