LOCATION
Remote (US)
TECHNOLOGY
AI-based Retinal Imaging
COMPANY HQ
Manhattan, New York
COMPANY SIZE
11-50 Employees
POSITIONOVERVIEW
Optain has spun out of Australian-founded Eyetelligence which was launched in 2019 based on the inventions of Professor Mingguang He. Optain received $12M in seed investments backed by Aegis Ventures and Northwell Holdings to launch an AI technology enabling early indication and disease prevention through retinal imaging.
We are hiring a Head of Clinical as the first internal clinical leader to own clinical development and execution for our U.S. Pivotal Study pursuing 510(k) clearance.
Northwell Holdings Article: AI Startup
Optain Article: Aegis Startup Studio
We have partnered with Jeff Dunkel, CEO of Optain to hire our Head of Clinical. This remote-based position will own the responsibility for all clinical trial strategies and tactical execution for our Pivotal IDE. The focus of this role is to write protocols, design budgets, manage GCPs and SOPs, and source and onboard a CRO as a clinical partner.
POSITIONDETAILS
- Design, plan, budget, manage, and oversee completion of all clinical study activities.
- Develop and implement a clinical quality management system (CQMS) to support all clinical research activities.
- Supervise quality of clinical operations and deliverables, ensuring exercises are completed in compliance with all local regulatory standards (e.g., ICH GCP, health authority, SOPs).
- Support in the preparation and submission of clinical protocols, FDA clearance-related documents, and other documents (including those related to IRB and ethics committees, QMS, FDA annual progress reports, and maintenance of clinicaltrials.gov listings).
- Lead in the activities related to clinical research including, but not limited to site identification, personnel training, report collection, and data analysis.
- Collaborate with both Optain team members Ascertain representatives on clinical operations strategy setting and own relationships with key external stakeholders including vendors and other partners to advance the clinical study activities within the venture.
Bachelor’s degree or equivalent in the life sciences, healthcare, or related field is required. Advanced degree in vision sciences, biology, clinical research, or a similar field is a plus. Expertise in clinical research design related to ophthalmology strongly desired.
- Experience owning global clinical trials ideally with SaMD or diagnostic technology
- A strong track record of successful trial initiation and execution.
- Minimum of 4 years of managerial experience required.
- Demonstrated understanding of clinical trial processes, and expertise in driving execution, from study start-up through study closure.
- Thorough understanding of FDA regulations, ICH Guidelines and GCPs governing the conduct of clinical trials.
- Prior experience with commercial medical product clinical research, creation, execution of clinical projects, and FDA validation activities (e.g., pre-submission, 510(k) pathway).
- Proven track record of collaboration with key opinion leaders, physicians, CROs, and clinical site teams.
- Strong written and verbal communication skills, organizational and prioritization skill. Must be able to work in a team environment.
- Ability and willingness to travel domestically, typically less than 10%, but rare instances of up to 40% during heavy study activities. Occasional international travel to R&D headquarters and trial sites may also be necessary.
COMPANYOVERVIEW
Optain is a revolutionary healthcare company that uses groundbreaking software and hardware technology to rethink care. We use the eye as a window to the body to improve the way we screen, manage and treat eye and systemic conditions. Optain is committed to expanding and improving care through the introduction of AI and machine learning technology into primary care and new care settings at an accessible price. At a systemic level, this not only ensures greater access to care but also promises to reduce the strains of an overburdened healthcare system.
Originally founded in Australia in 2019, Optain seeks to commercialize the inventions of Professor Mingguang He, a preeminent clinician-scientist and scholar in the field of ophthalmology. Optain has achieved regulatory clearance and commercial adoption of its product suite in global markets, including Australia and Europe.
Now, backed by Ascertain, a revolutionary partnership between Northwell Health, New York’s largest healthcare provider, and Aegis Ventures, an emerging venture creation studio backed by a leading global private investment firm, Optain is rapidly accelerating its growth trajectory. We are preparing for FDA clearance and US market entry of our first product, and advancing our R&D efforts for additional indications.
At Optain, we see a big opportunity to improve healthcare. We see through the eyes to the state of the whole body. We see precise screening, better treatment, more accessible care and a healthcare system that works for all. We see levels of care beyond what was previously thought as possible.
APPLY NOW
Head of Clinical
Remote (US)
PRESENTED BY
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