The Vice President of Clinical Research (VPCR) will be responsible for overall leadership of the clinical research and regulatory groups. The VPCR will develop and execute strategic clinical direction and clinical development activities of Pulsed Electromagnetic Field therapy (PEMF) products and programs. Key clinical activities will include protocol development, IRB submission, study support, clinical data base development and including clinical study report authoring. The VPCR will provide scientific expertise to investigators, study teams and vendors and insure that clinical trials for products follow regulatory and medical requirements. Will be responsible for strategizing and satisfying regulation requirements to obtain regulatory clearance to market in the U.S. The VPCR will work with engineers to discuss and agree on testing standards that must be adhered to as products near commercialization. Will also support the quality department in ensuring that the Company’s standard operating procedures meet the necessary regulations and that they are being followed. The VPCR will plan and help write regulatory submissions necessary for clinical studies and support regulatory in terms of strategizing for business development plans and budgets. necessary for clinical studies and or business development plans and budgets. Along with the CEO, and other members of the Leadership Team, the VPCR will represent Regenesis Biomedical externally with key stakeholders.
ESSENTIAL DUTIES & RESPONSIBILITIES
This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required, and it is anticipated that this will be 30% of work time.
Regenesis offers competitive pay, bonus plan, stock optons, relocation, health insurance benefits, matching 401k and a generous paid time off plan.
Regenesis Biomedical is an Equal Opportunity Employer