DMPK and Clinical Pharmacology Senior Scientist

Glaukos is looking for a motivated translational Sr. Scientist to join the Pharmacokinetics, Drug Disposition, and Clinical Pharmacology team. This team supports all phases of pharmaceutical R&D from discovery to registration by developing and executing the nonclinical and clinical ADME strategy for our novel pharmaceutical products. We are responsible for defining the relationship between drug exposure (e.g., concentrations in ocular tissue) and pharmacodynamic endpoints to select the optimal dose and dosing intervals for ocular drugs and drug/device combinations.

A successful candidate will be expected to participate on multidisciplinary R&D teams, provide PK and PK/PD subject matter expertise, and use their data and knowledge to influence project strategy. This individual will design, execute, interpret, and report studies involving small molecules and biologics delivered by a variety of routes in several nonclinical species. This individual will also design, execute, interpret, and report the pharmacokinetic components of clinical studies. Other responsibilities include applying a nonclinical to clinical translational approach (including use of modeling and simulation techniques) in advising project teams on optimal dosing regimen, projections for human efficacious doses, and optimal human starting doses.

Responsibilities

• Develop nonclinical pharmacokinetic and clinical pharmacology strategies for new molecular entities and repurposed drugs, including establishing PK/PD relationships, applying a translational mindset in identifying appropriate starting clinical doses for first in human studies, and characterizing human PK in a stage appropriate manner
• Design and execute in vitro and in vivo nonclinical ADME studies; interact with external CROs to perform required ADME studies including developing protocols, timelines, data analysis/interpretation and report writing.
• Maintain oversight of pharmacokinetic study budgets for assigned projects
• Represent DMPK and Clinical Pharmacology as the technical and scientific expert on project teams and actively participate in team discussions to support collaborative decision-making in drug development
• Develop quantitative, mechanistic, and translational mathematical models (PK, PK/PD, PBPK, etc.) using relevant modeling tools that inform nonclinical to early clinical translation, including human efficacious dose predictions and first-in-human dose selection.
• Effectively integrate and summarize pharmacokinetic data and modeling and simulation analyses into useable information for multidisciplinary project teams.
• Author pharmacokinetic study reports, modeling reports, and relevant sections of investigator brochures, briefing books, common technical documents, and other similar documents. Contribute clinical pharmacology subject matter expertise to authoring relevant sections of clinical protocols, statistical analysis plans, and study reports
• Author scientific publications and present at scientific conferences.

How You'll Get There:

• PharmD or PhD in relevant scientific field such as pharmacokinetics, pharmacometrics, clinical pharmacology, biological/pharmaceutical sciences, bioengineering with 0-4 years of industry experience
• Strong understanding of ADME-PK principles and the application of ADME-PK data to supporting research, nonclinical development, and clinical development
• Ophthalmic drug development experience is highly desired
• Hands-on experience using one or more relevant modeling and simulation software (e.g. NONMEM, Monolix, R, S-Plus, Phoenix NLME, MATLAB, Berkeley Madonna, Simbiology, SIMCYP, Phoenix WinNonLin, etc.)
• Strong critical thinking skills and demonstrated ability to communicate with team members across broad disciplines
• Highly motivated, self-driven, and detail oriented; can perform well both working independently and in team settings
• Excellent oral and written communication skills
• High degree of flexibility with ability to adapt to different projects and teams