Position Overview

Pivotal role providing medical/surgical perspective to the company’s clinical studies, regulatory filings, sales, marketing and training programs. The Sr. Director of Medial Affairs will also be responsible for establishing and overseeing the product safety department which includes operational, project management, and administrative leadership, direction and oversight for all product safety related operations in the company. Responsibilities include the monitoring, processing and analyzing of product safety data and their reporting as mandated by global and regional regulatory requirements. Job duties:
  • Serve as the primary scientific and clinical support resource for the Company, including communicating scientific and medical information with physicians.
  • Provide feedback regarding scientific and clinical strategy.
  • Develop and maintain relationships with key opinion leaders and clinics.
  • Build advocacy for Company’s existing and future products among thought leaders, including physicians, key academic centers, professional organizations, etc.
  • Data Safety Monitoring Board (DSMB) and Clinical Event Committee (CEC) management.
  • Establish and maintain high degree of knowledge in market place, stay current on leading edge product development efforts and provide perspective to the business on the treatment landscape.
  • Support clinical and medical training needs of customers and distributors.
  • Collaborate with academic centers, and support product adoption at centers of excellence.
  • Develop and provide input to clinical protocols.
  • Provide strategic and substantive assistance to publication/promotional planning, preparation and review.
  • Provide support to the review of requests for grants and sponsorships.
  • Represent Company at professional and medical meetings, congresses, conferences, advisory boards, local symposia, distributor-sponsored meetings, outreach meetings at key institutions and in interactions with thought leaders.
  • Handle medical issues that may arise from customers regarding Company products.
  • Work closely with the leadership team, Clinical Research, Regulatory Affairs, Marketing.
  • Additional duties and responsibilities as assigned.
    1. Medical Doctor (MD) degree is required.
    2. Minimum of 5-7 years clinical affairs experience required.
    3. Neurosurgery/ Endovascular experience or training preferred.
    4. Seven to ten years’ experience in the medical device industry or equivalent combination of education and experience.
    5. Extensive knowledge of neuro anatomy and physiology.
    Desired Qualifications
    1. Ability to work well in a team environment.
    2. Detail oriented
    3. Proven analytical abilities and organization skills.
    4. Excellent written, oral communications and presentation skills.
    5. Ability to work independently yet engage in collaborative decision making, to complete tasks in a timely fashion, and function in a rapid-paced environment.
    6. Ability to comprehend technical documents and concepts.
    7. Ability to establish strong relationships with peer groups, professional organizations, and other outside parties to further departmental and corporate objectives & goals.
    8. Demonstrated increasing responsibility in development of key opinion leadership, data analysis, field training, publication planning and grant applications.
    9. Ability to build high level medical/scientific knowledge, to grasp complex concepts quickly and to disseminate information.
    10. Develop a thorough understanding of regulatory guidelines such as FDA and CE mark process.
    11. Proficient computer skills (e.g., MS Office)