The Translational Neural Engineering Laboratory (http://www.tnelab.org) in the University of Minnesota Department of Psychiatry is seeking a clinical research lead to act as high-level orchestrator of multiple trials of advanced brain stimulation therapies for brain disorders. Our laboratory develops technologies for treating a variety of serious illnesses, including PTSD, major depression, addiction, and obsessive-compulsive disorder. Most of our work involves âœresponsive❠or âœclosed loop❠technologies that sense and respond to patientsâ™ brain activities. 

Studies either ongoing or starting up, which would be part of your portfolio, include:

⢠Deep brain stimulation for obsessive-compulsive disorder 
⢠Closed-loop invasive neurostimulation for severe depression
⢠Invasive neurostimulation for chronic central pain (such as post-stroke or facial pain)
⢠Biomarkers of suicidality recorded from the electroencephalogram
⢠Cognitive biomarkers of transcranial magnetic stimulation for depression
⢠Non-invasive brain stimulation to improve emotional resilience

We are specifically seeking a candidate who has clinical experience with brain or nervous system disorders and an interest in ongoing clinical work in this space. We hope to make this a long-term role, sustained by ongoing developments in the above spaces and expansion into new indications. You will be working at a high level of independence, in many cases substituting for the laboratory principal investigator(s). 

Responsibilities of this position will include:

Regulatory (33%):
â¢Develop and write Investigational Device Exemption (IDE) and Institutional Review Board (IRB) protocols for clinical trials of neurostimulation therapies, primarily for small-scale Early Feasibility pilots.
â¢Supervise and train coordinators and regulatory staff in ensuring all regulatory requirements are met and documented for clinical trials, including but not limited to IRB and FDA reports/filings, electronic regulatory binders, and study report forms.
â¢Maintain awareness of and update study practices to reflect ongoing developments in regulatory guidance related to neurotechnologies.

Administrative/Financial (33%):
â¢Develop, maintain, and track study budgets and associated documents, including budgets associated with grant submissions.
â¢Maintain liaison and strong working relationships with study financial sponsors, device manufacturers, representatives of regulatory bodies, data analytic staff, and University administrators.
â¢Coordinate high-level or mission-critical aspects of clinical studies, such as study device implantation, storage and proper handling of investigational product, data safety and monitoring board liaison, and harmonization of research procedures across studies.
â¢Evaluate, hire, onboard, and generally supervise study staff across the clinical portfolio. The number of direct reports may vary from 2 to 10 depending on study status.
â¢Manage study and portfolio staffing by forecasting staffing needs, hiring and training staff, and managing workloads and project timelines.
â¢Serve as a representative on various teams and committees making decisions and recommendations on behalf of the laboratory. These will include national scientific meetings or cross-institutional harmonization meetings.

Clinical/Scientific (33%):
â¢Develop strategic plan for initiation and execution of clinical trials. This will include funding, regulatory, and recruitment goals, with appreciation of the complex interlock between these.
â¢Perform a limited set of advanced study procedures (e.g., adjustment of implantable neurostimulator parameters) under physician supervision.
â¢Collaborate with investigators, project managers, and other study staff, particularly clinical research coordinators and technicians in collecting standard rating scales and assessments. 
â¢Develop and maintain standard operating procedures, followed by quality control review of collected data.
â¢Recruit and successfully activate sites for studies, including meeting with site personnel on behalf of the PI.
â¢Contribute to and draft publication-quality reports of study progress and outcomes. This will include both textual and graphical design, with writing to communicate to audiences across a wide range of education and sophistication.
â¢Develop and maintain study scientific procedures in consultation with domain experts. This will include development of study proposals to funding bodies and sponsors.
â¢Review ongoing study outcomes and monitoring data and recommend changes to study design as needed to achieve scientific goals.
â¢Learn and maintain awareness of the scientific and clinical literature related to brain stimulation for neurocognitive illnesses, sufficient to develop and describe the scientific rationale underlying study designs.

 

Required Qualifications:

Requires BA/BS with at least 8 years of experience or advanced degree with 6 years of experience and prior oversight of a small department or cross-disciplinary team.

â¢Clinical degree permitting performance of low-risk study procedures under physician supervision. A wide range of degrees, including nursing, psychology, social work, or medicine may qualify.
â¢At least 2 years of prior experience in a research setting. This does not need to be academic.
â¢In good ethical and professional standing sufficient to participate as an investigator on Federally funded research studies.

Preferred Qualifications:
â¢Doctoral-level clinical degree
â¢Prior experience in clinical practice or evaluation in mental disorders
â¢Prior experience developing, leading, and/or publishing clinical research
â¢Prior experience in developing funding proposals for scientific or clinical studies, particularly proposals to the National Institutes of Health
â¢Prior experience in independently developing regulatory documents for clinical studies
â¢Prior experience in neurostimulation (not necessarily brain stimulation) and/or medical device evaluation

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