Senior Manager Biomarker Operational Quality (contract) 26295-1

Vertex’s extensive clinical pipeline has broadened into new disease areas and treatment modalities, which includes the discovery of new genetic disease variants. The identification of novel genetic disease variants has refined our clinical development process. The personalized, precision nature of our medicines has driven our need for an Associate director who will provide insights and direction for transitioning IDE from clinical development to commercialization into CDx and in vitro diagnostic (IVDs), a subset of medical devices.

Key SKILLSET:

• Extensive knowledge and experience as a CDx developer and sponsor
• Extensive knowledge and experience as Drug sponsor and how to provide oversight of CDx developer
• SME of CDx development process end-to-end
• Extensive knowledge of CDx and IVD Regulatory requirements

DESCRIPTION:

• Identify risks or gaps with current processes for CDx (Research to Commercialization)
• Provides key inputs (deliverables) for CDx development and validation for CDx developers
• Develop required clinical validation documentation information
• Develop Quality agreement template between Drug sponsor and CDx developer.
• Assist in developing drafts SOPs for transitioning clinical IDE to regulatory to commercialization.

$75-$85/hr

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice.   Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners

(collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at privacyadministrator@atriumstaff.com.

If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email.

No C2C or Third-Party Vendors