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Director, Clinical Compliance
$147k-210k (estimate)
Full Time | Medical Technology
1 Month Ago
Glaukos is Hiring a Director, Clinical Compliance Near Aliso Viejo, CA
Job DescriptionGLAUKOS #DareToDomore Director, Clinical ComplianceFounded in 1998, Glaukos is publicly traded ophthalmic medical technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Our global headquarters is in Aliso Viejo, California, and we have additional locations in the United States, Canada, United Kingdom, Germany, Japan, Australia and Brazil.
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)
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.
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.
- 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.
- 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.
- 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.
- 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.
- 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 they pertain to clinical research.
- Understand and interpret complex scientific and regulatory issues.
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.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Medical Technology
SALARY
$147k-210k (estimate)
POST DATE
05/27/2024
EXPIRATION DATE
07/11/2024
WEBSITE
glaukos.com
HEADQUARTERS
SAN CLEMENTE, CA
SIZE
200 - 500
FOUNDED
1998
TYPE
Public
CEO
THOMAS W BURNS
REVENUE
$200M - $500M
INDUSTRY
Medical Technology
Related Companies
About Glaukos
Glaukos is an ophthalmic medical device firm that creates micro invasive glaucoma surgery options for patients.
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The job skills required for Director, Clinical Compliance include Leadership, Risk Management, Internal Audit, etc. Having related job skills and expertise will give you an advantage when applying to be a Director, Clinical Compliance. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Director, Clinical Compliance. Select any job title you are interested in and start to search job requirements.
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