SR Scientist - Clinical Pharmacology

Hiring By - Biostaffic

 BioPharma

Job Highlights

Not Disclosed

Associate

Posted 4 months ago
Job details

How will you make an impact?


Glaukos is looking for a motivated translational 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.

What will you do?

  • 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 will you get here?

  • 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
  • Salary Range: 100-123K*

*If you have any questions about the salary range - let's discuss!



Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.

Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we’re a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.

We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Moreover, Glaukos Corporation has been Certified as a Great Place to Work the last three years!

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.


ABOUT US

Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device—the iStent®—in the United States, followed by our next-generation iStent inject® device in September 2018 and iStent inject® W in September 2020.

In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases.

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 located in San Clemente, California with additional locations in Waltham 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.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

Experience:

  • Associate

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 11, 2024
Company Overview
Glaukos Corporation
Glaukos Corporation

Current Openings: 0

At Glaukos, our focus is to develop and lead the global ophthalmic market with novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases—therapies that advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide.
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