Director, Clinical Compliance

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.