Opportunity Details

The Senior Director, Clinical Compliance is responsible for leading a team to ensure that clinical research activities are conducted in compliance with regulations and standards. This role focuses on risk management, issue management, and monitoring to drive a common approach to quality and compliance. The Sr. Director works closely with Quality Assurance teams and other functional groups to optimize inspection readiness and oversee quality performance metrics.

The Sr. Director of Clinical Compliance is expected to streamline and standardize quality processes and templates, utilizing data to identify drivers of change and recommend process improvements. This role also involves providing oversight of Corrective and Preventive Actions (CAPAs) to completion, ensuring all CAPAs have relevant owners assigned and engaged. The ideal candidate will have a minimum of 15 years of experience in the biotech/pharmaceutical industry, with experience in CROs, R&D outsourcing, or procurement roles.

This position requires strong leadership skills to manage a team of Clinical Compliance and Risk Management professionals. The Sr. Director will define strategy and methodology for functional risk/issue management, create annual risk management plans, and provide oversight of CAPAs. The goal is to build a quality culture within the Development Operations team and enhance compliance capabilities within the client's organization.