Position Overview

Responsible for development of global clinical strategy for MVI consistent with its overall scientific, regulatory, and business goals and objectives. Lead the execution of global clinical research programs, including pre-market and post-market clinical research departments. Responsible for the leadership of the Medical Affairs department. Job duties:
  • Provide leadership, strategic insight, direction, and implementation of worldwide clinical research and medical affairs programs.
  • Provide strategic input, participate in development, and lead successful execution of global clinical strategies and implementation plans to achieve the company’s strategic goals.
  • Provide strategic, scientific, and operational direction for current and potential clinical trials. Provide strategic input in development of pre-market and post-market clinical research programs to support product regulatory approvals, post-market product surveillance and post-market clinical follow up (PMCF).
  • Interact on a regular basis with company leadership to ensure clinical programs are aligned with the company business objectives.
  • Leading clinical research function, identify and recruit appropriate talent to complement existing staff, and identify and work with outside vendors to best meet performance and timing requirements. Recruit, hire, manage, and develop a world-class clinical and medical affairs team.
  • Direct the development of systems, practices, and processes to ensure efficient and effective clinical operations including clinical trial management, data analysis and final study reports.
  • Represent the business with medical professionals involved in clinical research with the company and support communications with regulatory bodies, as needed.
  • Manage budgetary requirements and ensure compliance of expenditures to meet budget for worldwide clinical and medical affairs programs. Develop functional annual operating budgets for in house (and outsourced) clinical functions to meet long-term company and department objectives.
  • Build advocacy for company’s existing and future products among thought leaders, including physicians, key academic centers, professional organizations, etc.
  • Provide leadership and oversight to the Medical Affairs department including product clinical safety related operations (as applicable to pre-market and post-market clinical research), scientific research of clinical references, and medical writing.
  • Provide leadership and oversight to clinical study design committee.
  • Perform additional assignments as required.
    1. Master’s degree in Life Sciences or related field.
    2. Minimum twelve (12) years of applicable experience in a global clinical research environment.
    3. Minimum of eight (8) years of management experience leading clinical research and medical affairs organizations.
    4. Experienced and respected senior clinical executive in the medical device industry.
    5. Demonstrated success in domestic and international clinical programs (US, EU, China, and Japan).
    6. Demonstrated strong business acumen with an understanding of the financial implications of the clinical research.
    7. Experience with utilizing outside consultants and service providers in support of clinical validation studies and trials as well as a publication strategy.
    8. Experience with pivotal clinical programs supporting PMA submission.
    9. Hands-on experience in design, setup, and management of the conduct of clinical trials and clinical studies for both pre-market and post-market activities in all target markets.
    10. Working knowledge of US and International clinical trials laws and regulations.
    11. Working knowledge in scientific research of clinical references and medical writing requirements.
    12. Proven ability to communicate with key clinicians and executive management.
    13. Good understanding of clinical evidence and the US reimbursement process, other countries (China, Japan, EU are a plus).
    14. Strategic thinking and ability to lead clinical research and medical affairs functions.
    Desired Qualifications
    1. PhD or MD is desired.
    2. Preferred experience running an implantable medical device trial through regulatory approval.