Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives . With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,400 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.
Patients First | Innovation | Winning Culture | Heart Recovery
JOB RESPONSIBILITIES:
- Provide Strategic leadership for the design and execution of clinical studies on a global basis to achieve optimal speed, quality and economy.
- Direct the development of protocols and government documents and the sponsoring and execution of clinical studies in compliance with pertinent regulations.
- Participate in the review of regulatory submissions for product approvals.
- Provide input on the strategic formulation of protocols.
- Direct the work of clinical investigators to prepare publications, presentations, etc. of study findings.
- Interface with government agencies on product application and compliance.
- Subject Matter Expert to the management team, sales force and others regarding Abiomed’s clinical research, leading to physician adoption and real-world practical use.
- Attend seminars and meetings as Abiomed’s SME.
- Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
DESIRED QUALIFICATIONS:
- MD in cardiology, preferably with expertise in interventional cardiology and/or heart failure.
- 12+ years of experience directly supporting clinical research or similar experience in medical device
- Must have 8+ years of managerial experience with demonstrated success in organizational development, leadership, and budgetary responsibility.
- Advanced knowledge of medical terminology and knowledge of clinical and outcomes research study design in addition to expertise with GCP (Good Clinical Practices) and regulatory compliance guidelines for clinical trials.
- Demonstrated success in developing complex clinical affairs strategies across multiple product lines across multiple multi-national geographies.
- Ability to travel internationally up to 40%
Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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