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Vice President, Clinical Research & Medical Affairs

Regenesis Biomedical, Inc.


Location:
Scottsdale, Arizona 85250
Date:
07/20/2017
2017-07-202017-08-19
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Clinical Operations
  • Medical Affairs
  • Medical Doctors
Regenesis Biomedical, Inc.
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Job Details

 

 

Regenesis Biomedical is developing next generation therapeutic devices for persistent post-operative pain and inflammation and a new focus on Peripheral Neuropathy and Painful Diabetic Peripheral Neuropathy (PDPN). We are dedicated to making a difference in the lives of patients and their families who bravely face these difficult healthcare challenges everyday. 

This is a unique opportunity to be a major contributor to the success of a well-positioned, private equity owned growth stage medical device company.  This position is located in Scottsdale, AZ. 

POSITION SUMMARY 

The V.P., Clinical Research and Medical Affairs (VP-CRMA), is responsible for overall strategic clinical direction and clinical development activities of Pulsed Electromagnetic Field therapy (PEMF) products and programs, clinical data base development and outcomes research, including development, implementation, research writing and strategic partnerships. The VP-CRMA will design and oversee clinical trials for products that are in compliance with regulatory and medical requirements. The VP-CRMA is the ultimate medical policy decision maker for the Company. Along with the CEO, and other members of the Leadership Team, the VP-CRMA 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.
  • Responsible for the management of all clinical research and medical personnel.
  • Develop and lead a Medical Advisory Panel
  • 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.
  • Interface with our product development team to help define target product profiles and successfully translate those into clinical development.
  • Act as the primary spokesperson for the Company with key opinion leaders at medical conferences and advisory boards, building and maintaining relationships consistent with commercial and development objectives.
  • 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 product reviews, label expansion or reimbursement coverage.
  • Have P&L and budgetary responsibility for clinical research development and regulatory activities, providing strategic input to the annual and long range budgetary process.

 

Requirements

KNOWLEDGE & SKILL REQUIREMENTS

  • Substantial clinical development and execution experience, handling multiple parallel programs.
  • 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 studies in humans.
  • Knowledge of FDA regulations and guidelines and experience in interactions with FDA personnel is essential; experience with other health authorities’ a plus.
  • Superb ability to work on teams and across partner organizations.
  • Flexible to work non-business hours and travel domestically and internationally.
  • Ability to make effective presentations on complex topics.
  • Possess excellent strategic planning skills, good judgment and strong decision making capabilities.
  • Effective leadership, people management, interpersonal, communication, and problem solving skills.
  • Team builder management style who is willing to be “hands on”.

 EDUCATION, EXPERIENCE & TRAINING REQUIRED

  • MD with Board-Certification with10ormoreyears experience (primary care, podiatry, or vascular preferred).
  • Multiple years of management experience leading a clinical group including clinical/medical affairs and clinical research operations.
  • Skilled interpreting and adapting   scientific clinical information for practical training and field application.
  • Prior publications demonstrating the ability to write clearly and accurately.
  • Experience in the development, conduct, and analysis of clinical trials, both within and outside of the United States.
  • Experience with regulatory submissions for pharmaceutical and/or medical devices preferred, both within and outside of the United States.
  • Experience in peripheral neuropathy market development preferred.
  • Ability and strong desire to “make things happen”.
  • Results-oriented work ethic and a positive, can-do attitude.
  • High personal values and ethical standards.

 

WORK ENVIRONMENT

 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.

Qualified candidates must apply online at www.regenesisbio.com/about/careers/

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

Minorities/Women/Disabled/Veterans

 

 

 

 

 

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