Jobs

    Director Clinical Affairs - Massachusetts, United States - Walker Cole International

    Walker Cole International
    Walker Cole International Massachusetts, United States

    3 weeks ago

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    Description

    Director of Clinical Affairs

    Walker Cole International are proud to be partnered with a private equity backed Diagnostics Company seeking a Director of Clinical Affairs.

    This is an excellent opportunity to build out the clinical function and kick start this businesses' entry into the Women's Health and Urology markets.

    As the Director of Clinical Affairs you will be responsible for:

    • Creation of and execution of clinical development plan and strategy
    • Oversight of all clinical trials from design through to close out
    • Selection of CROs and Vendors and any third party testing companies
    • Full ownership of all contracts and budget negotiations pertaining to the set up of clinical trials
    • Support regulatory team with the submission of US FDA submissions
    • Build and lead a cross functional clinical operations team

    Required experience for the Director of Clinical Affairs:

    • years of clinical research experience
    • years of medical device clinical research experience in the USA, including IDE and post-market
    • understanding of FDA regulations, ISO-13485, ISO-9001, GMPs, and related regulations pertaining to other markets outside of the US
    • II and III medical device experience is required
    • ability to lead teams and manage relationships with external vendors
    • life science degree

    Location: Massachusetts – Hybrid Onsite

    Salary: $160,000 - $220,000 (depending on experience)

    Clinical Operations | Clinical Affairs | Class II | Class III | Diagnostics | Medical Devices | Clinical Research | FDA | Regulatory Submissions | Testing |

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