Clinical Director

Atrium Medical   •  

Merrimack, NH

Industry: Biotech/Pharma

  •  

Less than 5 years

Posted 396 days ago

Job Details:

The duties of this position includes but not limited to:

Strategic planning and development
•Identification and analysis of new business opportunities for vascular/endovascular solutions including support for market access
•Authors and edits clinical documents and documents required for regulatory submissions to US and other global health authorities

Technical documentation
•Lead authoring and responsibility for clinical evaluation reports and benefit-risk analyses according to FDA guidelines and MEDDEV 2.7./1  and related guidelines,
regulations, processes
•Contributes and support risk management for vascular/endovascular devices

 

Medical & Clinical research

•Support for clinical trials regarding vascular/endovascular devices (e.g. protocol development, study report review)
•Author/prepare "white papers"/clinical monographs/investigator brochures
•Oversight of abstract, poster, manuscript, oral presentation development for scientific meetings and journals
•Supports clinical marketing processes including KOL management

Other:
•Contributes to the development and standardization of templates and related standard operating processes
•Contributes cross-functionally to the quality and regulatory groups for complaint and non-conformity assessment and clinical support
•Contributes and supports education and training programs


Background Experience:
•Clinical expertise as a Vascular Surgeon with at least 3 years of clinical experience
•Ideally MD/DO with 2+ years of experience in research and multiple publications
•Ideally basic knowledge in cardiac surgery / stenting / Cath lab
•Experience with Research and Writing critical evaluations
•Profound understanding of clinical guidelines and their application in clinical practice;  ability to identify ‘pain points’ along a disease
•Experienced in authoring Clinical EvaluationReports in accordance with MEDDEV requirements.

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