Job Description

How will you make an impact?

The Director, Clinical Compliance, based in Aliso Viejo, CA., will be responsible for developing, leading, implementing and conducting strategies and activities to assure Glaukos Clinical Research remains in compliance with applicable regulations and laws maintaining a constant state of audit readiness.

What will you do?

Clinical Standard Operating Procedures (SOP)

• Work with stakeholders to create clinical SOP’s, work instructions, forms and templates.
• Develop company strategy for continued review of clinical SOP’s, work instructions, forms and templates.
• Implement, lead and manage SOP deviation processes with the Clinical teams.
• Implement and support cross-functional quality and risk management activities.

Process Improvement

• Review of clinical research processes to drive and support in-house continuous improvement.
• Strategic planning to ensure resources are available to maintain clinical compliance.
• Delivers innovative strategies and solutions.

Standards and Regulations

• Develop a program to review external standards and regulations related to clinical research globally.
• Conduct gap analyses of current standards to Glaukos procedures and processes.
• Lead, in conjunction with key stakeholders, updates to Glaukos clinical processes.
• Consultation and direction on clinical regulations, guidance and expectations to business colleagues.
• Clinicaltrials.gov oversight.
• Track and collaborate with study managers to ensure clinicaltrials.gov postings are generated, maintained, updated and posted, as needed.
• Work with Medical Writing, Statistics and Data Management, Regulatory, Clinical Research and Chief Development Officer to review and approve initial and results postings for clinicaltrials.gov.

Internal clinical assessment

• Develop an internal clinical assessment program.
• Manage the execution of internal clinical audits for Clinical Research.
• Draft summary reports of internal clinical audits.
• Facilitate and lead cross functional internal audit corrective actions.
• Review of externally conducted clinical site audits and in the development of reactive measures.

How will you get there?

• Bachelor's degree required.
• Minimum of 10 years of clinical research experience, preferably in both device and pharmaceutical.
• Preferred 2 or more years’ experience in clinical quality.
• Knowledge of clinical study designs and protocols.
• Experience in addressing and drafting responses to regulatory agencies.
• Thorough understanding of the CFR, FDA/ICH guidelines, GxP and cGMP as pertaining to clinical research.
• Understand and interpret complex scientific and regulatory issues.

#GKOSUS

About Us

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.