This position will support the planning and implementation of clinical studies and the associated medical device training and operation for the development and study of the Pulse Tx technology for dermatology applications. The position will also oversee the use of the device for melanoma applications and other research projects in its early stages.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Oversees device logistics and operations for the use of the Pulse Tx device for dermatology, oncology and veterinary applications.
- Planning and implementing of multi-centre studies of clinical effects on skin lesions, with planned future studies for other non-skin tumor targets.
- Clinical trials with a medical device require oversight of device operation of clinical study personnel for investigator sites, device data log monitoring, occasional troubleshooting of software and hardware operations.
- Limited responsibility for overseeing clinical data collection of designated clinical study site personnel.
- Establish and maintain high quality relationships with investigators and their staff as part of overall relationship management process with key scientists and opinion leaders.
- Integrate data management as needed with planned data analysis of the clinical and scientific team
- Assist with development of product labeling, translation, and investigator brochures for clinical studies.
- Develop and/or maintain processes, procedures, and work instructions for system usage and train/monitor users accordingly for adherence to device operation instructions and study protocol requirements.
- Ensure that NCMR and CAPA are appropriately generated, documented, and closed in a timely fashion as defined in established procedure.
- Support internal audits and other regulatory compliant activities as requested
- Carry out responsibilities in accordance with the organization’s policies and applicable laws.
- Support the Pulse Biosciences Quality Policy and Quality System.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Demonstrated track record for supervising the training for and use of a medical device in a clinical trial with a protocol approved by an IRB or similar oversight entity
EDUCATION and/or EXPERIENCE:
- Requires at least 5+ years medical device experience
- BA/BS degree or equivalent experience required
Pulse Biosciences, Inc. is a clinical-stage medical device company using a novel and proprietary platform technology called Nano-Pulse Electro-Signaling or NPS. NPS can be tuned to induce a variety of cellular responses including secretion, apoptosis and necrosis by modulating the NPS pulse parameters, making it applicable to a wide variety of cell types and therapeutic applications. One of the more promising applications of NPS is the treatment of solid tumors, where pre-clinical data has shown that NPS provides effective local tumor control and initiates an adaptive immune response with a vaccine-like effect by inducing immunogenic apoptosis of the cells.
Send resume to: Careers@pulsebiosciences.com