Director, Clinical Compliance

<p class=""p1"">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 the eyesight of people worldwide. Because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company.</p> <br /><br />Base Salary Range: $144,300 - $187,600

Aliso Viejo, CA


<h4>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.</h4> <h4>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&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;inject&reg;&nbsp;device in September 2018 and iStent&nbsp;inject&reg;&nbsp;W in September 2020.</h4> <h4>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.</h4>

keywords: position summary,compensation,develop,analysis,implementation,leadership,medical,consulting,teamwork,experience,knowledge,education

Full time

Base Salary Range: $144,300 - $187,600

Overview: 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.
Responsibilities: <p><strong>Clinical Standard Operating Procedures (SOP</strong>)</p> <ul> <li>Work with stakeholders to create clinical SOP&rsquo;s, work instructions, forms and templates.</li> <li>Develop company strategy for continued review of clinical SOP&rsquo;s, work instructions, forms and templates.&nbsp;&nbsp;</li> <li>Implement, lead and manage SOP deviation processes with the Clinical teams.</li> <li>Implement and support cross-functional quality and risk management activities.</li> </ul> <p><strong>Process Improvement</strong></p> <ul> <li>Review of clinical research processes. to drive and support in-house continuous improvement.</li> <li>&nbsp;Strategic planning to ensure resources are available to maintain clinical compliance.</li> <li>Delivers innovative strategies and solutions.</li> </ul> <p><strong>Standards and Regulations</strong></p> <ul> <li>Develop a program to review external standards and regulations related to clinical research globally.</li> <li>Conduct gap analyses of current standards to Glaukos procedures and processes.</li> <li>Lead, in conjunction with key stakeholders, updates to Glaukos clinical processes.&nbsp;</li> <li>Consultation and direction on clinical regulations, guidance and expectations to business colleagues.</li> </ul> <p><strong> oversight</strong></p> <ul> <li>Track and collaborate with study managers to ensure postings are generated, maintained, updated and posted, as needed.</li> <li>Work with Medical Writing, Statistics and Data Management, Regulatory, Clinical Research and Chief Development Officer to review and approve initial and results postings for;</li> </ul> <p><strong>Internal clinical assessments</strong></p> <ul> <li>Develop an internal clinical assessment program.</li> <li>Manage the execution of internal clinical audits for Clinical Research.</li> <li>Draft summary reports of internal clinical audits.</li> <li>Facilitate and lead cross-functional internal audit corrective actions.&nbsp;</li> <li>Review of externally conducted clinical site audits and in the development of reactive measures.</li> </ul>
Requirements: <ul> <li>Bachelor's degree required.</li> <li>Minimum of 10 years of clinical research experience, preferably in both device and pharmaceutical.</li> <li>Preferred 2 or more years&rsquo; experience in clinical quality.</li> <li>Knowledge of clinical study designs and protocols.</li> <li>Experience in addressing and drafting responses to regulatory agencies.</li> <li>Thorough understanding of the CFR, FDA/ICH guidelines, GxP and cGMP as they pertain to clinical research.</li> <li>Understand and interpret complex scientific and regulatory issues.</li> </ul> <br /> <p><strong>Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.</strong>&nbsp;</p> <p>These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.</p> <p>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&rsquo;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.</p> <p>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 &amp; 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 two years!</p> <p>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.</p>