Glaukos Corporation
Clinical Research Director
Glaukos Corporation, Aliso Viejo, California, United States, 92656
Overview
How Will You Make an Impact? As the Clinical Research Director, you will lead cutting-edge clinical studies in ophthalmic innovation, guiding work from early product development through to clinical trials. You will help ensure that Glaukos products are safe, effective, and meet regulatory standards, driving life-changing advancements in eye health and patient outcomes. What Will You Do? Drive Study Execution : 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 : 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 high industry standards, and strengthen relationships with investigation partners. Collaborate Cross-Functionally : 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 : 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 : Build and develop a team of clinical research professionals, fostering a culture of excellence. Prior leadership in clinical research is crucial to guide the team and ensure top performance. Drive Enrollment : Proactively identify and address enrollment challenges, using creative problem-solving to ensure enrollment targets are met on time. Ensure Regulatory Compliance : Prepare and submit reports to external and internal stakeholders, maintaining a deep understanding of industry regulations to ensure compliance throughout study processes. Contribute to Process Development : Collaborate with Clinical Compliance to refine and develop SOPs and other department processes, leveraging experience to ensure operations are efficient and effective. How will you get here? Bachelor's degree required; master's and/or other advanced degree preferred in biological sciences, nursing, or health-related discipline. 12+ years of relevant clinical research experience, preferably in ophthalmology and medical devices, with 9+ years of direct study management. Minimum 4 years of supervisory experience in clinical settings. Combination products or pharmaceuticals necessary to be considered. Experience in ophthalmology and surgical procedures required. Proven leadership in managing multiple clinical trials, including CRA and vendor management, meeting milestones, and managing timelines. Strong skills in study auditing, site monitoring, adverse event reporting, and training CRAs. Expertise in negotiating/executing site and vendor budgets, analyzing study data, and preparing study reports. Experience with study design, protocol writing, and clinical study documentation while successfully problem-solving and cross-functionally collaborating with internal and external stakeholders. Ability to write SOPs and develop processes for improved quality and efficiency, with a willingness to travel as needed.
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How Will You Make an Impact? As the Clinical Research Director, you will lead cutting-edge clinical studies in ophthalmic innovation, guiding work from early product development through to clinical trials. You will help ensure that Glaukos products are safe, effective, and meet regulatory standards, driving life-changing advancements in eye health and patient outcomes. What Will You Do? Drive Study Execution : 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 : 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 high industry standards, and strengthen relationships with investigation partners. Collaborate Cross-Functionally : 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 : 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 : Build and develop a team of clinical research professionals, fostering a culture of excellence. Prior leadership in clinical research is crucial to guide the team and ensure top performance. Drive Enrollment : Proactively identify and address enrollment challenges, using creative problem-solving to ensure enrollment targets are met on time. Ensure Regulatory Compliance : Prepare and submit reports to external and internal stakeholders, maintaining a deep understanding of industry regulations to ensure compliance throughout study processes. Contribute to Process Development : Collaborate with Clinical Compliance to refine and develop SOPs and other department processes, leveraging experience to ensure operations are efficient and effective. How will you get here? Bachelor's degree required; master's and/or other advanced degree preferred in biological sciences, nursing, or health-related discipline. 12+ years of relevant clinical research experience, preferably in ophthalmology and medical devices, with 9+ years of direct study management. Minimum 4 years of supervisory experience in clinical settings. Combination products or pharmaceuticals necessary to be considered. Experience in ophthalmology and surgical procedures required. Proven leadership in managing multiple clinical trials, including CRA and vendor management, meeting milestones, and managing timelines. Strong skills in study auditing, site monitoring, adverse event reporting, and training CRAs. Expertise in negotiating/executing site and vendor budgets, analyzing study data, and preparing study reports. Experience with study design, protocol writing, and clinical study documentation while successfully problem-solving and cross-functionally collaborating with internal and external stakeholders. Ability to write SOPs and develop processes for improved quality and efficiency, with a willingness to travel as needed.
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