Job Description:

Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, one of the world’s leading causes of blindness. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, in order to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company’s second-generation MIGS device, the iStent inject® Trabecular Micro-Bypass System, was approved by the Food and Drug Administration, or FDA in June 2018. The company believes the iStent inject,® measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA. In June 2015, Glaukos completed an initial public offering and our shares are now traded on the New York Stock Exchange under the ticker symbol “GKOS”. The company was founded in 1998 and is based in San Clemente, California.

How you will make an impact?

The Director, Clinical Research, Device, based in San Clemente, CA will have oversight of the device portfolio of Glaukos products as related to Clinical Research, to include device trials, clinical study operations, supervision of assigned department employees, and development of department processes.  In addition, working closely with the Sr. Director, Clinical Science and Strategy, develop and execute clinical strategies for the device portfolio of Glaukos products.

What you will do?

·       Serve a leadership role in managing multiple device clinical research programs across all device platforms.

·       Working closely with Clinical Science and Strategy, assist with the development and execution of global clinical strategies for device products

·       Serve as clinical lead for all device development projects

·       Manage and ensure on time delivery of clinical deliverables to support regulatory submissions and project teams

·       May represent as clinical therapeutic expert in agency meetings

·       Assists with development and writing of study protocols. Ensures protocols are in compliance with appropriate regulatory requirements and Clinical Research written procedures.

·       Responsible for the development of the Clinical Investigator’s Brochure (if applicable).

·       In conjunction with Study Management and Data Management, responsible for the oversight of study Case Report Form development and associated data collection documents.

·       Responsible for the development of the Informed Consent Form template, ensuring all regulatory requirements are addressed.

·       Responsible for the development of study Monitoring Plans and all other study documents.

·       Along with Clinical Relations, assist in the development of patient recruitment materials.

·       Develops study training documents for sites and team members. Train team members on clinical study requirements.

·       Oversees the development of study surgery training materials (if applicable), with significant input from engineering, surgical specialists, and clinical relations.

·       Lead study project planning and problem resolution.

·       Plan and coordinate investigator meetings as needed.

·       Provide proactive leadership in identifying enrollment issues and recommending solutions so that enrollment targets are met.

·       Responsible for clinical department budget management for the device portfolio

·       Oversees all aspects of device clinical study execution:

o   Manages clinical study product supply in conjunction with manufacturing, including inventory projections, requests for shipping (including verification of essential documents), and accountability

o   Actively participates with site selection

o   Oversight of clinical studies from study initiation through study closure, including timeline development, milestone achievement, and budget projections

o   Works closely with Clinical Operations to oversee site monitoring/management activities of assigned CRAs.

o   Reviews adverse event data, surgical data (if applicable), and clinical study product accountability and alerts Clinical Management, Regulatory Affairs, and Medical Monitor as needed to ensure safety events and potential product issues are properly reported.

o   Communicates with sites, including leading study teleconferences, organizing investigator meetings, and traveling to sites as needed.

o   Negotiates study budgets with sites, assists with site contract execution, and administers grant payments.

o   Assists with ClinicalTrials.gov as needed.

o   Assists with selection of vendors.

o   Assists with development of budgets and contracts with vendors.

o   Manages vendors to ensure proper study execution.

·       Assists with development of clinical study reports (communications/reports to regulatory bodies, DSMB meetings, interim and final reports)

·       Participates in the preparation of regulatory submissions as needed.

·       Assures IRB reporting requirements are met.

·       Develops and provides progress reports to Clinical and Corporate Management as needed.

·       Responsible for process development within the clinical department in order to ensure quality, effective, and efficient clinical operations:

o   Contributes to SOP generation and associated documents

o   Reviews documents written by other department employees

o   Develops processes to assess compliance with SOPs and study processes, including metrics

·       Hires, trains, and supervises employees/contractors in order to ensure quality, effectiveness and productivity.  

·       Assigns projects with clear milestones and monitors progress to ensure timely completion.

·       Provides supervisor of assigned team members with feedback on performance and assists with development through assigned study tasks. 

·       Assists employees with developmental needs and provides development opportunities.

·       Develops relationships with key opinion leaders and clinical investigators.

·       Stays abreast of recent developments in ophthalmology and attends ophthalmic congresses on a periodic basis.

How you will get there?

·       Minimum 10 years relevant work experience in clinical research, preferably with experience in ophthalmology, pharmacology and medical devices.

o   At least 7 years with direct study management experience.

·       5 years of experience with supervision of clinical employees

·       Excellent project leadership skills and able to manage multiple clinical trials with the ability to meet milestones and manage timelines

·       Study auditing and site monitoring knowledge and ability to train CRAs

·       Experience with negotiating and executing site and vendor budgets

·       Experience with adverse event reporting and documentation

·       Able to analyze and summarize study data, and assist with writing study reports

·       Able to assist with study design and writing of protocols and all associated study documents

·       Knowledge of clinical study product management and requirements for verifying accountability

·       Excellent problem solving skills

·       Excellent written and verbal communication skills

·       Self-motivated and able to work independently, as well as within a team

·       Excellent organizational skills

·       Experience with writing SOPs and process development/improvement to increase quality and efficiencies

·       Must be willing and able to travel approximately 20%

·       Medical and ophthalmology terminology helpful

·       Exhibits personal integrity, credibility, and responsibility

Education:

·       Bachelor’s degree in biological science, nursing, or other health-related discipline preferred.

·       Advanced degree, M.D., O.D. or PhD preferred. 

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.

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