Manager overseeing Project Management team in Clinical Research at Sanford Health. Collaborating with Clinical Research Managers and guiding strategic research initiatives.
About the role
- Senior Clinical Research Director leading clinical trials for ophthalmologic diseases within AI-powered R&D firm. Driving breakthroughs in ocular treatments through strategic clinical leadership and collaboration.
Responsibilities
- Provide ophthalmology focused medical and scientific expertise to the cross functional project team to conduct the clinical studies from early phases to LCM programs
- Establish clinical development strategy and lead clinical team, collaborate with other medical and clinical scientific experts
- Develop or contribute to the regulatory documentation for the project(s)
- Responsible for the clinical part of regulatory documents for submission to regulatory bodies
- Designs the global clinical development strategy and generates the Clinical Development Plan
- Implements strategies to identify, monitor and resolve clinical program/trial issues
Requirements
- Medical Doctor (MD) and ophthalmology residency training required, fellowship training highly preferred
- Minimum 5 years of clinical trial and/or clinical development experience
- Fluent in English (verbal and written)
- Board certified or eligible in Ophthalmology
- Strong scientific and academic background with deep understanding of retina and eye diseases
- Clinical trial or pharmaceutical experience in ophthalmology
- Knowledge of drug development, ocular gene therapy, regulatory strategy
Benefits
- health insurance
- prevention and wellness programs
- at least 14 weeks’ gender-neutral parental leave
- thoughtful, well-crafted rewards package
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