Associate Director, Protocol Review Committee (PRC) Lead

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Position Summary:

The Protocol Management Office (PMO) at Clinical Center of Excellence (CCoE) ensures scientific rigor and quality of clinical documents within Drug Development (DD).  A critical component of the CCoE responsibilities is the oversight of the TA-aligned Protocol Review Committee (PRC) within DD. As an integral member of the PRC team, the PRC Lead helps achieve these objectives through leading the Therapeutic Area (TA) PRC process and supporting clinical teams through the process steps.  The PRC Lead will drive implementation of the PRC process, work collaboratively with key stakeholders to strive for the highest quality output and audit compliance documentation.

In addition, the PRC Lead role will work with peers to standardize the process. PRC Lead must have an innovative mindset, leveraging technology to continuously improve the PRC workflow. The Lead will also serve as a process expert supporting the Quality and the Governance process initiatives to help drive improvement activities aligned with the QMS programs. The PRC Lead role will also partner with Enterprise Operational Excellence to assist in driving execution of the Governance Model as well as support their continuous improvement efforts. The role will also be supporting other key enterprise projects as appropriate.

Key Responsibilities:

• Serve as process Lead for multiple TA specific PRC(s)

• Lead PRC process and work closely with PRC Chairs to drive the PRC meetings

• Ensure quality, scientific rigor and feasible to of planned studies in alignment with the endorsed strategy from strategic review and endorsement

• Facilitate cross functional clinical and scientific leadership review and endorsement of all new clinical study protocols and protocol amendments

• Oversee the Document Review process for Essential Protocol Elements & Revised EPEs, Statistical Analysis Plans (SAP) & Revised SAPs, Data Monitoring Committee (DMC) Charters & Revised DMC Charters, Independent Event Adjudication Charters, Study Steering Committee Charters (at the discretion of the TA Head), Asset Program Elements

• Guide each study team through PRC review to ensure document quality, through assessing team readiness, triaging appropriate review, clear documentation of decisions/approvals and process efficiency

• Lead projects to ensure continuous improvement of the PRC process

• Leverage technology and partner with IT, develop, refine and report outcome-based metrics for the PRCs

• Determine root cause and corrective actions for platforms and systems that affect PRC process and efficiencies, lead improvement efforts

• Help develop norms and standards, including best practices in meeting management and guidance for participants in processes, to be shared across DD

• Design comprehensive training programs and materials tailored to PRC member roles and responsibilities

• Deliver formal group training sessions and hold open office hours to provide direct support to our teams, answer questions, and reinforce protocol knowledge and best practices

• Use appropriate change management and communication principles

• Manage initiatives related to Quality and the Governance process

• Partner with QMS and governance to align with overall quality process strategy and execution with inspection ready mindset

• Represent PRC during inspections and audits, and support management of responses and CAPA resolution for clinical development related findings

• Contribute to CCoE and cross functional continuous improvement initiati