Clinical Research Scientist
Neuronetics is a commercial stage medical technology company focused on designing and marketing products that improve the quality of life for patients who suffer from psychiatric disorders. NeuroStar Advanced Therapy is the leading transcranial magnetic stimulation (TMS) device, and was the first TMS device designed for clinical use for the treatment of patients with Major Depressive Disorder. We are passionate about transforming patients’ lives and the practices of our physician customers. Malvern, PA or remote locations are acceptable.
The Clinical Research Scientist is responsible for assisting in the development and execution of the clinical strategy for new indications. The Clinical Research Scientist will review and analyze clinical publications and TrakStar data for technical content to support new indication submissions.
• Work with Dir Strategic Clinical Development on strategies for each indication submission.
• Review competitor 510K submissions and publications for substantial equivalence data.
• Search relative clinical publications for supporting data.
• Perform retrospective analysis on published clinical data.
• Work with the Clinical Data Analyst to define search queries for supporting data.
• Work with the Clinical Data Analyst to develop analytics to support the 510K submission.
• Support development and authoring of documents for 510K submissions.
Education and Experience:
• Technical/Science or related Degree.
• At least 5 years’ experience in medical research and/or development.
• Working knowledge of statistical analysis.
• Self-directed, resourceful, and able to get work done without significant input.
• Good organizational skills, attentive to details, and able to multitask.
• Strong problem-solving skills and ability to deal with changing priorities.
• Strong written, verbal, and presentation skills.
• Experience with statistical methods used for clinical trials.
• Working knowledge of 510K submissions.