Mission:
Eversight’s mission is to restore sight and prevent blindness through the healing power of donation, transplantation and research.
Our Culture Story:
Imagine you’re unable to see a loved one’s eyes as they smile. You can’t see their face as they call your name, or your own face in the mirror as you start each day. This is what life is like for millions of people coping with vision loss.
Now, imagine your eyesight is restored. You can suddenly see all the color and sights of the world around you. Your life is transformed. This is the power of eye donation, corneal transplantation and vision research. This is what Eversight team members make possible every day.For more than 75 years, Eversight has enabled donors and their families to give the gift of sight. We ensure that their gifts transform the lives of those suffering from blindness, and advance new treatments and cures for blindness.
Summary
Eversight’s Clinical Research Director is responsible for leading scientific studies and clinical development work to promote the optimal operation of the Research and Development pipeline. This position coordinates the day-to-day activities of scientific experiments, clinical trials, and/or regulatory work, intentionally focusing on developing new or improved clinical service lines and/or products.
Fair Labor Standards Act Status:
Exempt
Essential Job Functions
- Works hand-in-hand with the Vice President of R&D to guide clinical and regulatory strategies and their operationalization into programs and trials
- Ensures regulatory compliance for all R&D activities by interpreting and adhering to applicable laws, guidelines, and industry standards, including FDA, IRB, and other regulatory requirements.
- Develops and implements processes to maintain compliance, support audits, and collaborate with cross-functional teams to address regulatory challenges.
- Monitors cornea/anterior segment marketplace evolution and leads the development of relevant and financially viable products and services to expand the depth of R&D pipeline.
- Initiates and leads the operational and regulatory planning, executing, and successful delivery of R&D pipeline program sand studies.
- Leads the development of essential study documents such as protocols, report forms and instructions, study operations manuals, informed consent forms, study management/tracking tools, and monitoring plans.
- Initiates and manages the day-to-day activities for clinical trials, including managing protocol amendments, overseeing data review activities, and communicating with investigators/sites as appropriate.
- Performs laboratory duties and other administrative assignments in compliance with Eversight, Eye Bank Association of America, and state and federal regulations.
- Initiates, leads, and executes peer-reviewed scientific publications, conference presentations, and funding proposals to secure funding.
- Maintains relationships with service area staff, consultants, collaborators, and vendors as required.
- Handles proprietary or sensitive information in a confidential, professional manner.
- Demonstrate a commitment to the Mission and Values of Eversight.
- Other Duties: New tasks, duties and responsibilities may be added at any time, with or without notice to the employee. This job description is not intended to cover or describe all of the tasks, duties and responsibilities the employee may be required to or asked to perform.
Qualifications
Education: An advanced degree in biological human sciences is required.Experience: Experience with preparing and interacting with global health authorities (e.g. FDA) is highly preferred. Participation in drug/device development activities leading to successful registration is preferred.Skills: Must possess a strong understanding of clinical and scientific methods and approaches used in clinical development, from FIH to registration; experience with regulatory processes and registration is preferred.
Must possess the ability to develop strong client relationships and build trusted partnerships with external professional constituents and internal teams. Ability to manage multiple tasks simultaneously and independently define priorities based on organizational goals and objectives. Excellent oral and written communication skills. Must have outstanding critical thinking and problem-solving skills.Must have the ability to travel (domestic and international) as needed.
Benefits:
- Medical, dental and vision insurance
- Generous paid time off
- 403(b) retirement plan with company match
- Tuition reimbursement
- Paid parental leave & more
Work Environment & Physical Demands
Administrative functions: Work is primarily performed in a typical office environment. While performing the administrative duties of this job, the employee is regularly required to sit for long periods. Routine use of a computer. Limited noise, room temperature fluctuation, and dust are possible.Laboratory functions: Work is performed in a laboratory setting or patient care setting, such as a hospital operating room or morgue, with potential exposure to communicable diseases or hazardous materials.The work environment and physical demand characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Organizational Relationship
Reports to the Vice President or C-Suite Staff
80000.00 To 105000.00 (USD) Annually
