DMPK and Clinical Pharmacology Senior Scientist presso Glaukos Corporation
Glaukos Corporation · Aliso Viejo, Stati Uniti d'America · Onsite
- Professional
- Ufficio in Aliso Viejo
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
Company
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.
Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.
Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra “We’ll Go First,” which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.
Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol “GKOS”. Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
