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Vice President of Clinical Affairs, Nashua, NH (Preferred)

Vice President of Clinical Affairs, Nashua, NH (Preferred)

Conformal Medical was started in 2016 to develop the next generation of left atrial appendage occlusion implants used to prevent strokes in patients with Atrial Fibrillation (AFib). The CLAAS® System is an innovative technology that simplifies the procedure, improves the patient experience, and may improve outcomes. The company has completed first-in-human trials and is preparing for US pivotal clinical trials.

This position is a key member of the leadership team responsible for developing the clinical trial strategies and direct execution of the program. They foster relationships with KOLs to provide clinical insight to guide the programs.  They oversee the internal and external clinical team and management of all operational aspects of the clinical trials.  Develop a collaborative study team through interfaces with the sites, vendors, clinical proctors, regulatory/quality and research and development staff to ensure a fully integrated multi-functional team is supporting the clinical trials. Direct all operational aspects of the clinical trial on time and within budget in accordance with company goals.  

Responsibilities
Develop and implement worldwide clinical trial strategies.
Direct the internal Clinical Affairs organization
Manage/Hire the internal clinical staff
Develop and manage department and study budget
Obtain and organize clinical trial agreements and budgets.
Ensure Clinical Quality Assurance is met.
Establish relationships with KOL’s and sites to ensure study meets expectations of all stake holders.
Author clinical data reports as required for regulatory organizations.
Manage publication strategy.
Interface with FDA on any clinical matters.
Ensure clinical trials meet enrollment deadlines.
Present progress/trial metrics and issues to Board of Directors.
Prepare and present clinical affairs progress reports for Conformal Management Team and Board of Directors.
Interface with CMO on all clinical affairs matters.

Qualifications
15-20 years of medical device Clinical Affairs experience.
A history of clinical operations experience.
Knowledge and experience running large, IDE class 3 medical device trials in support of PMA submissions.
Knowledge of cardiovascular physiology and structural heart anatomy
MS or BS degree in a technical discipline (nursing, biology, chemistry, engineering).
Good organization and writing skills.
Good communication with all levels of the company, hospitals, and physicians.


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