Senior Manager Biomarker Operational Quality (contract) 26295-1

Vertex Pharmaceuticals

110d • $75 - $85

About The Position

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.

Requirements

• 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

Responsibilities

• 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

Benefits

• Overtime pay in accordance with federal and state requirements

What This Job Offers

• Number of Employees: 5,001-10,000 employees