About the Company
CereVasc is a medical device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. The Company’s first product, the eShunt™ System, has been developed to treat hydrocephalus, a potentially life-threatening disease also known as “water on the brain.” The eShunt System has the potential to disrupt a 60-year-old standard of care that is fraught with high failure and complication rates that typically result in patients requiring multiple revision surgeries over the span of their treatment.
Developed by two world-renowned neurosurgeons at Tufts Medical Center, the eShunt System is delivered endovascularly and avoids the need for invasive surgery, extended hospitalization, and post-procedure pain management typically associated with the current surgical treatment of hydrocephalus by using conventional shunt devices.
The eShunt System will address a $5 billion market opportunity with a novel alternative to conventional treatments, and has the potential of positively impacting the lives of more than 400k hydrocephalus patients in the US and EU. Conventional treatment possesses a failure rate exceeding 40% by the 2nd year after shunt placement, with each failure requiring patients to undergo additional surgeries.
CereVasc is currently preparing for a first-in-human clinical trial of the eShunt System and subsequent U.S. clinical studies, and needs a Director of Clinical Development to manage the development and execution of its clinical trials.
About the Position
Reporting to the Senior Vice President and General Counsel and in consultation with Company regulatory personnel and other key stakeholders, the Director of Clinical Development will lead the strategic development of clinical trial design and execution of the overall clinical evaluation of CereVasc Class III medical devices.
This position will be responsible for developing and implementing a clinical trial strategy, from the identification and training of clinical trial site personnel through the completion of all subject follow up visits and data collection. Works closely with regulatory team members to support regulatory submissions to the FDA and other agencies.
- Develop strategic direction and priorities for clinical evaluation of Company’s products, working with engineering, quality, operations, and regulatory leadership to define clinical development projects including objectives, work plans, milestones and deliverables.
- Design and execute pivotal clinical trials in line with Good Clinical Practice, Company SOPs, FDA guidelines, including prioritizing indications, choosing appropriate investigators, study populations and endpoints, planning and executing statistical analysis, and identifying risks.
- Provide overall clinical trial site management from qualification/start-up to closeout, including support for clinical trial agreement negotiation, site training and initiation, CRF review, protocol and regulatory compliance, device accountability, and site visit reports.
- Actively support the regulatory submission process, working closely with regulatory stakeholders in the development and support of strategies to obtain marketing authorization for Company products.
Preferred Qualifications & Experience
- BS or higher in a technical or clinical discipline (e.g., engineering, biology/life sciences).
- 5+ years clinical research experience in a medical device setting.
- Experience with a Class III medical device strongly preferred.
- Previous experience in a pivotal IDE trial with a neurovascular device preferred
- Experience with Electronic Data Capture (EDC) systems.
- Demonstrated experience supporting major regulatory submissions – PMA, 510(k), etc.
- Excellent analytical skills required; some formal training in statistics is preferred.
- Positive, self-motivated, detailed, and hands-on, with the ability to work independently as well as collaboratively in a dynamic start-up environment.
- Ability and willingness to travel.
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