As a valued leader, you will support the Chief Medical Officer and bring a high degree of scientific acumen and robust clinical development experience to advance an innovative brain neuromodulation device therapy from clinical trials and to patients. You will design, plan, and implement clinical trials in a start-up environment, collaborating with internal cross-functional teams, and contract organizations. You will create, cultivate and maintain communicative relationships with clinical investigators, medical experts, as well as members of the medical and scientific communities. Responsibilities also include adverse event monitoring/safety signal assessments and clinical trial safety responsibilities. Coordinates and develops reporting information for reports submitted to the FDA. Participates in investigator training, site training, advisory board preparation, protocol generation, clinical study report generation, etc. Monitors adherence to protocols and oversees study completion.
- Provide cross functional Clinical Development leadership for internal and external team members in the delivery of clinical studies:
- Provide a primary role in the strategic planning of clinical studies and programs, including authoring study designs, developing clinical trial synopsis/protocols, milestones, key deliverables
- Provide oversight/management of and collaboration with Contract Research Organization (CRO) partners.
- Provide support and oversight to all other functional areas of the study teams throughout the lifecycle of the study (startup, maintenance, closeout) in order to ensure data integrity, resolve and/or escalate issues, achieve alignment, and adhere to study goals and timelines.
- Act as primary contact for medical communication to ensure medical safety within studies, develop and maintain relationships with sites and Investigators.
- Provide medical monitoring, which includes reviewing study participant eligibility, protocol interpretation, coding support, protocol deviation review, and data cleaning in collaboration with Clinical Operations and Data Management.
- Review statistical output from medical device clinical trials and registries and determines appropriate evaluation, interpretation, and presentation of data.
- Author, review, and/or provide strategic input into:
- Clinical sections of regulatory documents including, regulatory submissions, investigator brochures, and briefing documents
- Study specific documents such as study protocols/amendments, informed consent documents, case report forms, placebo justifications, and clinical study reports.
- Scientific publications, manuscripts, posters, or other documents intended for external audiences
- Present as needed to worldwide regulatory agencies, investigational meetings, Data Monitoring Committee (DMC), Regional Advisory Boards, Medical Advisory Board (MAB), Safety Advisory Board (SAB), and interacts as needed with Key Opinion Leaders (KOL), Primary Investigators and Site Investigators to support clinical and product strategies.
- Join the CMO in representing Clinical Development at Regulatory Authority Meetings
- Present the clinical development aspects of a project and clinical trial results at internal or external meetings.
- Communicate to Senior Management and relevant functions any potential issues, risks or changes to the Clinical Development Plan
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
- Post-graduate degree (MD, PhD, PharmD) or international equivalent
- Training in Neurology/Neuroscience, preferably with medical device experience
- Minimum 5-7 years of clinical/research experience in the pharmaceutical and/or device industry
- Ability to travel at least 30%
- Ability to work in a team setting as well as function as an individual contributor
- Ability to work efficiently and under tight timelines
- Ability to communicate effectively
- Ability to be flexible in an ever-changing environment
- Ability to think strategically and be able to anticipate problems before they occur
- Ability to be proactive in finding solutions to issues
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Project)
- Must be able to perform all essential functions of the position, with or without reasonable accommodation