POSITION SUMMARY:        

The Senior Director, Medical Affairs will report to Chief Medical Officer of Abiomed, and will be responsible for the development and execution of the company’s medical affairs and clinical research strategy, with an emphasis on provider education, external communications, and clinical research publication. This physician will use her/his cardiology expertise and clinical trials experience to craft and execute a scientifically sound research and publication roadmap for Abiomed, as well as a communications strategy to educate the medical community about Abiomed’s product portfolio.

This individual will serve as the primary interface between the Medical Office and other internal functions, as well as external stakeholders. This individual will collaborate with Abiomed’s existing medical affairs teams including the Chief Medical Officer. As a key member of the CMO leadership team, this individual will develop methods, techniques, and evaluation criteria for projects, programs, and people. This leader oversees complex issues where analysis of situations or data requires an in-depth knowledge of research and medicine as well as applicable regulations.

Abiomed’s primary markets are in the US, Germany, and Japan. The Senior Director, Medical Affairs will represent Abiomed’s business around the world, engaging clinicians and thought leaders across the nation as well as in Europe and Japan. The responsibilities will include frequent travel both domestically and internationally.

Additionally, the Senior Director, Medical Affairs will:

• Design a clinical strategy and Research Plan to expand company growth through evidence-based investigations, peer-reviewed publication, and effective communication of study results
• Develop the internal organizational structure and all necessary external relationships required to execute the Research Plan
• Develop strategies that incorporate use of non-traditional data sources such as registries and real-world data as part of the plan
• Serve as a backup to the Chief Medical Officer with respect to internally and externally facing activities including interfacing with the external medical and scientific community
• Interface with clinical operations to ensure proper oversight / monitoring of Abiomed sponsored clinical trials
• Interface with the Abiomed publications team to ensure a robust strategy to communicate research results
• Establish and maintain a professional and credible image with key physicians, consultants, vendors and lead the development of posters and oral presentations for scientific meetings
• Work in collaboration with Regulatory Affairs to prepare CE Mark, IDE, 510(k), PMA and related regulatory filings, providing clinical interfaces with regulatory agencies as appropriate
• Work in collaboration with Clinical Research Operation to ensure adequate safety review and reporting in ongoing clinical trials and registries
• Maintain knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to ABIOMED products
•  Not be responsible for engineering or product development activities

CANDIDATE QUALIFICATIONS:    

The successful candidate will be an MD or equivalent with post-graduate training resulting in eligibility for United States Medical Board certification in cardiology, preferably with expertise in interventional cardiology and/or heart failure.

This individual will have excellent written and oral scientific communication skills, a solid track record of clinical trials investigation and publication, and a rich knowledge of patient management. This individual will serve as evangelist and educator to the leaders of the cardiology community, able to discuss Abiomed’s portfolio meaningfully with practicing cardiologists and make an immediate educational impact.

• Minimum of 3-5 years of experience in clinical medicine, preferably interventional cardiology or heart failure practice
• Excellent communication skills; ability to effectively engage practicing clinicians, scientists, key opinion leaders, industry executives, and regulatory bodies
• Demonstrated success in trial design and execution with diverse research teams
• Excellent analytical skills required; formal training in epidemiology and/or statistics is preferred
• Industry experience in a medical device organization (medical affairs, clinical research, or pharmacovigilance) is preferred but not required
• Experience working with senior executives and a Board of Directors is preferred
• Organizational experience leading teams in both a direct reporting and matrix environment
• Strong interpersonal, leadership, motivational, and team-building skills and the ability to work in a multicultural, global environment
• Ability to make critical strategic business decisions and manage competing stakeholder expectations
• Ability to travel frequently, both domestically and internationally
• Proficient in computer software and technology required to manage and publish clinical trials

EDUCATION:

An MD or equivalent with post-graduate training resulting in eligibility for United States Medical Board certification is required. Board certification in cardiology is strongly preferred, with a preference toward expertise in interventional cardiology and/or heart failure.