Director of Scientific Affairs - Cardiac

United States of America, Indiana, Indianapolis

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Job Summary:

Responsible for working in partnership with the global medical and scientific affairs departments and global business areas to develop and support the medical and scientific vision and strategies.  Provides strategic direction on medical differentiation of products during product development, designs and supports clinical trials to generate medical evidence, publishes results of clinical trials and promotes and leads the exchange of medical and scientific information about disease diagnosis and disease management.  Serves as spokesperson on medical, scientific and clinical matters to internal and external constituents.

Provides strategic decision making, leadership and planning including the efficient and effective use of resources.  Achieves results through the leadership of managerial, professional and/or support staff. Delegates responsibilities to subordinate staff.  Sets policy and strategy for own department. Has full HR responsibility for direct and indirect reports. Has full budget responsibility for assigned functional area or departments.

Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.

What You Do:

  • Oversee the direction, planning and interpretation of clinical trials/research and data collection activities. Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports.  Develop, plan and interpret clinical trials.
  • Direct diagnostic development focus to disease management; capture additional economic value for new diagnostics through outcomes-based studies that demonstrate improved patient benefits and cost effectiveness.
  • Work with the Research and Development department in determining clinical feasibility of new products.  Contribute to medical differentiation and risk analysis.
  • Serve as global liaison.  Work with the clinical and medical groups within the global organization to identify and implement collaborative studies, regulatory activities and other programs.  Keep abreast of international research in related fields.
  • Serve as global liaison.  Work with the clinical and medical groups within the global organization to identify and implement collaborative studies, regulatory activities and other programs.  Keep abreast of international research in related fields.
  • Responsible for project training (clinical study) and preparation of technical and scientific publications.
  • Serve as clinical spokesperson in a wide range of venues, both internally and externally, such as professional society forums, customer sites and relevant corporate functions.
  • Provide medical and scientific expertise input for product development.  Generate clinically robust and ethical outcomes studies.  Direct pre- and post marketing clinical trials by providing expert input in the design, execution and evaluation of trials that support the efficacy of medical devices.  Complete health hazard evaluations to determine potential patient impact.  Coordinate the use of outside medical opinions and ensure collaboration of internal medical and scientific resources.
  • Provide input to new business and market development activities in North America, including new business ideation and touch-points with North American market development.  Shape product development and drive the establishment of new standards of care.  Increase sales force disease management knowledge and understanding to enable appropriate clinical adoption of new technologies.  Increase credibility and clinical voice through physician relationships.

Who You Are:

  • Doctoral degree in medicine, dentistry or veterinary medicine with 2 years clinical experience or (PhD) Chemistry, Molecular Biology, Microbiology or other scientific discipline with strong clinical expertise
  • 8+ years experience in FDA regulated industry with thorough knowledge of product development and clinical studies to support regulatory submissions or generate medical evidence / outcome data
  • Experience in dealing with clinicians, senior business leaders and regulatory authorities

Preferred:

  • Medical Doctor preferred with strong clinical skills
  • 5+ years’ experience in the IVD field with thorough knowledge of clinical studies
  • Scientist (PhD) with strong clinical expertise
  • Proven leadership and managerial skills
  • Extensive cardiac background and knowledge

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