Clinical Research Director

As the Clinical Research Director, you will take the helm of cutting-edge clinical studies that push the boundaries of ophthalmic innovation. Your leadership will be crucial in shaping the future of eye care, from the earliest stages of product development through to clinical trials, ensuring that our groundbreaking Glaukos products are safe, effective, and meet stringent regulatory standards. This is more than a role—it's a chance to drive life-changing advancements in ophthalmology that will directly enhance patient outcomes and transform lives.

If you're ready to lead the next wave of innovation in eye health, this is your opportunity to make a profound impact.

• Drive Study Execution
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  Manage all aspects of clinical studies from initiation to closure, including site selection, product management, and communication with study sites. Strong project management skills are essential to tracking milestones and achieving targets.
• Support Protocol Development
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  Contribute to the creation of study protocols in compliance with regulatory standards. Your expertise will help ensure protocols align with clinical operations and regulatory requirements, meet the highest industry standards, and contribute to a strong relationship between Glaukos and our investigation partners.
• Collaborate Cross-Functionally
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  Partner with Clinical, Regulatory, R&D, and Marketing teams to design and implement successful clinical research programs. Your experience in managing multi-disciplinary projects will drive innovation and seamless integration.
• Develop Budgets & Contracts
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  Lead the development of clinical study site budgets, negotiate contracts, and manage vendors. Your ability to manage complex budgets and maintain vendor relationships will ensure smooth study operations.
• Lead and Develop High-Performing Teams
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  Build and develop a team of clinical research professionals, fostering a culture of excellence. Prior leadership experience in clinical research is crucial to guide the team and ensure top performance.
• Drive Enrollment
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  Proactively identify and address enrollment challenges, using your creative problem-solving skills to ensure enrollment targets are met on time.
• Ensure Regulatory Compliance
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  Prepare and submit reports external and internal stakeholders, maintaining a deep understanding of industry regulations to ensure compliance throughout study processes.
• Contribute to Process Development
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  Collaborate with Clinical Compliance to refine and develop SOPs and other department processes, leveraging your experience to ensure clinical operations are efficient and effective.
• Oversees all aspects of clinical study execution
  • Manages clinical study product, including inventory projections, requests for shipping (including verification of essential documents), and accountability
  • Assists with site selection
  • Project manages from study initiation through study closure, including timeline development, milestone achievement, and budget projections
  • Oversees site monitoring/management activities of assigned CRAs. Reviews adverse event data, surgical data, and clinical study product accountability and alerts Regulatory Affairs, Clinical management, and Medical Monitor as needed to ensure UADEs and potential product issues are properly reported
  • Communicates with sites, including leading enrollment teleconferences, organizing investigator meetings, and traveling to sites as needed
  • Negotiates budgets with sites, assists with site contract execution, and administers grant payments
  • Assists with Clinical Trials.gov as needed
  • Assists with selection of vendors
• Assists with development of budgets and contracts with vendors
• Manages vendors to ensure proper study execution
• Communicates with vendors as main study contact
• 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.
• Submits reports to IRBs as required.
• Develops and provides progress reports to management as needed.
• Assists with investigator meetings at glaucoma-related conferences as needed.
• Responsible for process development within the clinical department in order to ensure quality, effective, and efficient clinical operations:
  • Writes SOPs and associated documents or reviews documents written by other department employees
  • 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…