The Vice President of Clinical Research (VPCR) will be responsible for overall leadership of clinical research. The VPCR will develop and execute strategic clinical research direction and development activities of Pulsed Electromagnetic Field therapy (PEMF) products and programs. Key clinical activities will include protocol development, IRB submission, study execution and support, clinical data base development and clinical study report authoring and editing. The VPCR will provide scientific expertise to investigators, study teams and vendors and insure that clinical trials follow regulatory and medical requirements. The VPCR will be responsible for strategizing and satisfying regulation requirements to obtain regulatory clearances. The VPCR will work with engineers to discuss and agree on testing standards that must be adhered to as products near commercialization and support the quality department in ensuring that the Company’s standard operating procedures meet and follow the necessary regulations. The VPCR will help plan and write regulatory submissions for product development plans. The VPCR will develop and submit the budget necessary for clinical studies and/or business development plans. Along with the CEO, and other members of the Leadership Team, the VPCR will represent Regenesis Biomedical externally with key stakeholders.
ESSENTIAL DUTIES & RESPONSIBILITIES
Conduct clinical studies, clinical trials, data analysis and data interpretation required for product introduction, marketing and label expansion.
Provide oversight and, when necessary, lead in taking innovative ideas from proof of concept through regulatory strategy, including filing and approval.
Responsible for the management of all clinical research personnel.
Review and approval of scientific data supporting products and product labeling.
Ensure clinical development programs meet quality and safety standards required by medical and regulatory agencies.
Maintain outstanding relationships with all key internal customers and regulatory agencies. Interact with the FDA on a proactive, independent and frequent basis.
Interface with our product development team to help define target product profiles and successfully translate those into clinical development.
Strengthen clinical knowledge of staff and serve as a resource for clinical information to both staff and key initiatives.
Represent the Company with regulatory agencies for clinical product reviews, label expansion or clinical research support of reimbursement coverage.
Remain current in all appropriate regulations and participate when possible in continuing education.Have P&L and budgetary responsibility for clinical research development, providing strategic input to the annual and long-range budgetary process.
Have P&L and budgetary responsibility for clinical research development, providing strategic input to the annual and long range budgetary process.
KNOWLEDGE & SKILL REQUIREMENTS
Substantial clinical development and execution experience, handling multiple parallel programs.
Experience in either the pain management or treatment of peripheral neuropathy preferred.
Current medical device industry experience, people management, project management and budget management experience required.
Broad scientific, technical and regulatory understanding of most of the functions involved in the development of a Class II medical product.
Experience designing and overseeing a clinical development program, with emphasis on human studies.
Knowledge of FDA regulations and guidelines and experience in interactions with FDA personnel is essential; experience with other health authorities a plus.
Ability to work on teams and across partner organizations.
Flexible to work non-business hours and travel domestically, and, internationally in the future.
Ability to make effective presentations on complex topics.
Possess excellent strategic planning skills, good judgment and strong decision making capabilities.
Effective “hands on” leader with strong people management, communication and problem solving skills.
EDUCATION, EXPERIENCE & TRAINING REQUIRED
An undergraduate degree is required; a scientific or clinical degree is highly preferred; an advanced degree in science or business is preferred.
A minimum of 5 years’ management experience in clinical research is required.
Skilled in interpreting and adapting scientific clinical information for practical application.
A proven track record of product approvals including a successful track record of project management including the establishment of milestones, design records and technical filings.
Experience in the development, conduct, and analysis of clinical trials.
Results-oriented work ethic and a positive, can-do attitude.
High personal values and ethical standards.
Experience with regulatory submissions for medical devices preferred.
Experience in pain or diabetic and peripheral neuropathy market development preferred.
Ability to locate to Scottsdale, AZ, near the Company’s headquarters.
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, health insurance benefits, matching 401k and a generous paid time off plan.
Regenesis Biomedical is an Equal Opportunity Employer
Internal Number: 20958
About Regenesis Biomedical, Inc.
Regenesis Biomedical (www.regenesisbio.com), is a privately held company focused on noninvasive regenerative medicine. Located in Scottsdale, Arizona, Regenesis has developed, patented, and now makes the Provant® Therapy System. The company was founded back in 1997 by two N.I.H. scientists who became very interested in the potential for pulsed electromagnetic field energy. Provant® Therapy delivers electromagnetic energy which reduces post-operative pain and edema. The Regenesis environment exemplifies the Company’s core values of dedication, innovation, integrity, respect, excellence, compassion and teamwork.