What are the responsibilities and job description for the Clinical Research Director position at Glaukos Corporation?
How Will You Make an Impact?
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.
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 the highest industry standards, and contribute to a strong relationship between Glaukos and our 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 experience in clinical research is crucial to guide the team and ensure top performance.
- Drive Enrollment: Proactively identify and address enrollment challenges, using your creative problem-solving skills to ensure enrollment targets are met on time.
- Ensure Regulatory Compliance: 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: Collaborate with Clinical Compliance to refine and develop SOPs and other department processes, leveraging your experience to ensure clinical 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.
#GKOSUS
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.
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 the highest industry standards, and contribute to a strong relationship between Glaukos and our 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 experience in clinical research is crucial to guide the team and ensure top performance.
- Drive Enrollment: Proactively identify and address enrollment challenges, using your creative problem-solving skills to ensure enrollment targets are met on time.
- Ensure Regulatory Compliance: 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: Collaborate with Clinical Compliance to refine and develop SOPs and other department processes, leveraging your experience to ensure clinical 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.
#GKOSUS