Job Details

How You'll Contribute:

The Sr. Director, Clinical Research will be responsible for leading and overseeing clinical research activities for the development of ophthalmic medical devices. In this role, the Sr Director will manage a suite of research programs within the assigned product portfolio, including the design, execution, and oversight of clinical trials, clinical compliance, regulatory requirements and collaboration with key stakeholders to drive successful product development and advance Glaukos business objectives. The Sr. Director will manage a team of clinical research professionals, supporting their career development.

What You'll Do:

Develop and lead the company's clinical research execution strategy for pre and postmarket device programs.

Collaborate with cross-functional teams, including regulatory affairs, medical writing, biostatistics, data management and programming (BDMP), R&D and clinical supply, to drive clinical development initiatives.

Responsibilities

• Oversees all aspects of clinical study execution: Actively guides site selection
• Serves as clinical representative on project core team meetings within product portfolio.
• Lead and execute clinical development plans in early stages of product development.
• Project manages from study initiation through study closure, including timeline development, milestone achievement, and budget projections
• In conjunction with Clinical Operations, track site monitoring/management activities of assigned CRAs.
• Reviews adverse event data, surgical / treatment data, and clinical study product accountability.
• 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
• Provides proactive leadership in identifying enrollment issues and recommending solutions so that enrollment targets are met.
• Negotiates budgets with sites, assists with site contract execution, and administers grant payments.
• Manages clinical study product, including inventory projections, requests for shipping (including verification of essential documents), and accountability
• Assists with ClinicalTrials.gov as needed
• Assists with selection of vendors, including managing budgets and contracts with them
• Supports the development and writing of study protocols.
• Ensures protocols are in compliance with appropriate regulatory requirements and clinical operations written procedures.
• Support the preparation and submission of regulatory documents, including 510Ks and PMAs.
• Establish and maintain relationships with key opinion leaders (KOLs), clinical investigators, and external partners.
• Manage project planning, staff training, and investigator meetings as needed.
• Develop and provide progress reports to management as needed.
• Responsible for process development within the clinical department to ensure quality, effective, and efficient clinical operations: Contribute to clinical SOPs and associated documents development / reviews documents written by other department employees
• Working with Clinical Compliance, assist with development of processes to assess compliance with SOPs and study processes, including metrics.
• Support harmonization of clinical templates/documents/processes
• 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 assigned team members with feedback on performance and assists with development through assigned study tasks.
• Assists employees with developmental needs and provides development opportunities
• Stays abreast of recent developments in ophthalmology and attends ophthalmic congresses on a periodic basis.

How You'll Get There:

• Bachelor's Degree biological science, nursing, or other health-related discipline. Required
• Master's Degree Preferred
• 15+ years relevant work experience in the clinical research industry, preferably with experience in ophthalmology and medical devices
• At least 9 years with direct study management experience
• 7 years of experience with supervision of clinical employees
• Excellent project leadership skills and able to manage multiple clinical trials, including CTA and vendor management, and ability to meet milestones and manage timelines
• Experience with negotiating and executing site and vendor budgets
• Experience with adverse event reporting and documentation
• Ability to analyze and summarize study data, and assist with writing study reports
• Ability to assist with study design and writing of protocols and all associated study documents
• Proven track record of strong cross-functional skills, interacting effectively both internally and externally Required
• Knowledge of clinical study product management and requirements for verifying accountability
• Surgical and ophthalmology knowledge