Preclinical Ophthalmology Study Director

Powered Research, LLC performs contract research services specializing in novel and established nonclinical models in ophthalmology. We offer a great opportunity to work hard, have fun, make a difference in critical medical research, and directly contribute to our rapid growth.

We are seeking a highly skilled and motivated Preclinical Study Director specializing in ophthalmology to join our research team. As a Preclinical Study Director, you will be responsible for planning, coordinating, and overseeing non-GLP preclinical studies focused on ophthalmic treatments and interventions. You will work closely with a multidisciplinary team of researchers, technicians, and sponsors to ensure the successful execution of preclinical studies in compliance with regulatory guidelines and industry best practices. The ideal candidate will have a strong background in ophthalmology research and extensive experience in preclinical study management.

Responsibilities:

• Design and Develop Study Protocols: Collaborate with cross-functional teams to develop and refine study protocols, ensuring they align with project goals, regulatory requirements, and scientific standards specific to ophthalmology.
• Study Planning and Coordination: Coordinate and manage all aspects of preclinical studies, including study design, timeline development, budgeting, resource allocation, and communication with internal teams, external vendors, and sponsors.
• Study Oversight and Management: Oversee and monitor the execution of preclinical studies, including coordinating study activities, tracking progress, troubleshooting issues, and ensuring adherence to study protocols and quality standards.
• Data Analysis and Reporting: Collaborate with data scientists and technical writers to analyze study data, interpret results, and prepare accurate and comprehensive study reports. Ensure that data is properly collected, recorded, and maintained throughout the study.
• Team Collaboration: Work closely with cross-functional teams, including scientists, technicians and veterinarians to facilitate effective communication, promote collaboration, and achieve study objectives.
• Vendor Management: Identify and manage relationships with external vendors, contract research organizations (CROs), and other service providers to ensure the timely delivery of high-quality preclinical study services.
• Scientific Expertise: Stay updated with the latest advancements in ophthalmology research, preclinical study methodologies, and relevant regulatory requirements. Provide scientific expertise and guidance to the research team.
• Documentation and Compliance: Ensure accurate and timely completion of study documentation, including study plans, company guidelines and SOPs; study reports, and IACUC submissions.
• Continuous Process Improvement: Identify areas for process improvement, implement best practices, and contribute to the development of standard operating procedures and quality control measures to enhance the efficiency and effectiveness of preclinical study operations.

Qualifications and Skills:

• Ph.D. or equivalent degree in ophthalmology, vision science, pharmacology, or a related field.
• Minimum of 5 years of experience in preclinical study management within the preclinical pharmacology; drug development or ophthalmology field.
• Strong knowledge of ophthalmology research methodologies, ocular anatomy, physiology, and common ophthalmic diseases.
• Familiarity with preclinical study design, execution, and regulatory requirements (GLP, ICH guidelines).
• Experience in managing and coordinating multiple preclinical studies simultaneously.
• Excellent organizational, project management, and problem-solving skills.
• Proficient in data analysis and statistical software.
• Strong written and verbal communication skills.
• Ability to work effectively in a team-oriented and fast-paced environment.
• Attention to detail and ability to maintain accurate records.
• Demonstrated ability to lead and manage cross-functional teams.

Job Type: Full-time

Pay: $100,000.00 - $140,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Education:

• Doctorate (Required)

Work Location: Hybrid remote in Durham, NC 27709

Salary : $100,000 - $140,000