Abiomed
Manager/Director of Medical Affairs
Job#: 17MA-03
Positions: 1
Posted: 05/15/2017
Job Type: Full Time
Location: Danvers, MA
Department: Medical Affairs
Salary: Commensurate with Experience
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Job Description

The Manager/Director of Medical Affairs reports directly to ABIOMED’s Vice-President and Chief Medical Officer and is responsible for planning, implementing and executing the clinical research program of the company.

Primary Duties and Responsibilities:

  1. Implement and lead a clinical strategy that will expand company growth through evidence based medicine and investigations
  2. Lead the development, management, and execution of a comprehensive publication plan for ABIOMED products and clinical research initiatives in partnerships with external investigators and Global Medical Affairs staff. This is a key function to the role.
  3. Work closely with the Chief Medical Officer to develop protocols for experimental studies, first-in man investigations and larger multicenter clinical trials and registries.
  4. Expand and maintain, in partnership with executive team, Global sales and marketing teams a network of key opinion leaders that will help expand our growth.
  5. Work in collaboration with Director of Regulatory to prepare CE Mark, IDE, 510(k), PMA and related regulatory filings. Provide clinical interfaces with regulatory agencies as appropriate.
  6. Lead the development and approval of slide presentations to be used by the Clinical Affairs Field team in answering customer questions on ABIOMED trials/publications. Assist in the development of posters and oral presentations for scientific meetings and peer-reviewed papers for publication
  7. Regularly make presentations to customers, experts in the field of Ventricular Assist Devices and senior staff members.
  8. Establish and maintain a professional and credible image with key physicians, consultants, vendors, and co-workers and act as the company clinical and medical expert in Europe in the cardiovascular area.
  9. Maintain knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to ABIOMED products.




Skills/Requirements

Job Qualifications:

  1. M.D degree with strong cardiovascular knowledge strongly preferred. Master’s degree or PhD in medical/scientific field would be considered in case of strong proven knowledge of cardiovascular field, Catheterization lab and cardiac surgery.
  2. Minimum of 3 years of experience in medical device clinical research.
  3. Proven prior experience in scientific data interpretation, presentation and publication is required.
  4. Expertise with Good Clinical Practices (GCP) and regulatory compliance guidelines for clinical trials.
  5. Experience and expertise in study/trial design and execution highly desired.  .
  6. Proven ability to work in a multicultural, global environment.
  7. Role requires frequent travels in US and Europe (~15%) of the time.

 

ABIOMED is an Equal Employment Opportunity/Affirmative Action employer.  We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.

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