Gyroscope: Vision for Life
Gyroscope Therapeutics is building something special – a company to preserve people’s sight and fight the devastating impact of blindness around the world. And if we are successful, our gene therapies and surgical devices will offer people the chance to see what they otherwise would have missed.
To be successful we need the right people. People who have passion for helping patients. People who can work as one toward a common goal, have fun and together bring forward the best ideas. People who celebrate success and embrace failure as an opportunity to learn and grow. If you are one of these people, we would love to meet you.
Reporting to the VP Clinical Development, this role will lead the design of clinical development strategy and direct the implementation of clinical trials of gene therapies in ophthalmic indications. Responsibilities include safety oversight, clinical contribution to regulatory documents, analysis of study results, and preparation of reports for the clinical programme(s) assigned
- Lead clinical development programme strategy for assigned programme(s)
- Develop expertise in clinical and translational outcomes and endpoints and contribute to the translational research strategy
- Lead activities relating to clinical study design, preparation of protocols, clinical trials oversight, data analyses and written study reports
- Support business development and assessment of opportunities for in-licensing and collaboration
- Collaborate with external partners: CROs and other vendors, including image reading centres, academic partners, industry groups
- Provide medical input to Competent Authority and Ethics Committee/IRB submissions and support interactions with same
- Develop and maintain relationships with KOLs and investigators, develop a broad network of experts in the ophthalmology space
- Provide medical monitoring oversight and serve as the primary contact for the medical review of safety reports for pharmacovigilance
- Mentor Clinical Project Managers to assure medical training on the indication of interest
Education and Experience Requirements
- Professional credentials as a physician (MD) or equivalent (e.g. OD, PharmD).
- Minimum of five years of clinical development experience
- Experience in ophthalmology or rare diseases is a positive, but is not required
- Experience in global drug development
- Translational medicine or early clinical research experience
- Thorough knowledge of clinical trial processes including a strong grasp of international guidelines and regulations (FDA, ICH, and GCP)