Head, Clinical Data Management

The Head of Clinical Data Management (CDM) is fully accountable for all clinical data management activities in support of the clinical pipeline. This includes, but is not limited to, execution and ownership of the CDM operating model, oversight of internal staff and external CDM partners, and cross-functional leadership for the delivery of high quality and reliable clinical data to enable internal decision making, regulatory approval, and market acceptance.

The incumbent interacts with senior level management, partners with external vendors, collaboration partners and provides cross functional strategic direction and is accountable for building and managing a team across functions to identify risks and opportunities as well as innovative approaches to clinical data management. The Head of Clinical Data Management is critical to the success of our clinical trials and the integrity of data that supports regulatory submissions and decision-making.

In this role, a typical day might include:

• Establishing and driving global data management strategy related to resourcing, technologies and processes to increase efficiency, innovation and data quality.

• Defining and executing the vision and long-term goals for the department.

• Leading the global data management function to provide data collection, cleaning, and integration expertise in support of global development projects including all disease areas and business units; ensure functional strategy supports the portfolio priorities while also remaining close to the business and portfolio

• Accountability for meeting annual goals, objectives and deliverables for both internal and external Clinical Data Management (CDM) partners.

• As the business owner of the Clinical Scientific Data Lake, develop, implement, and oversee the clinical data model and standards in support of the global portfolio.

• Building efficient and compliant processes to support regulatory inspections

• Driving the organization towards high quality, efficiency, and standards

• Ability to effectively structure an organization to manage the anticipated growth in the global product pipeline.

This role might be for you if have expertise leading the following areas:

Data Management and Data Integrity Oversight:

• Ensure timely and high-quality data management deliverables supporting the Regeneron clinical study portfolio

• Responsible for Sponsor Oversight of Data Management deliverables and activities performed by Strategic Partners, CROs, and 3rd Party Vendors

• Lead implementation of clinical data management best practices (e.g., cross-functional data review, emerging data collection technologies, etc.)

• Prepare for and facilitate regulatory audits and inspections, ensuring readiness and compliance.

Data Operations and Vendor Management:

• Accountable for resourcing algorithms that enable appropriate staffing

• Serve as Subject Matter Expert and data-specific liaison for Process, Training and Compliance and other internal initiatives/projects

• Design and implement clinical data management standard processes, ensuring engagement with key partners on critical processes such as cross-functional data review; issue escalation, etc.

• Build and maintain relationship with vendors for the purpose of providing outsourcing solutions, functional solutions and staff augmentation services, as well as building new and/or improved data management capabilities

Metrics, Analytics and Reporting:

• Lead development of Clinical Data Management metrics, represent CDM function in projects and initiatives related to the reporting and analytics capabilities, including but not limited to Dashboards, Portfolio level performance and productivity and predictive analytics/reporting

To be considered for this opportunity, you must have the following:

• Minimum Bachelor’s Degree

• 17+ years of clinical data management experience in a pharmaceutical or biotech setting

• 12+ years of functional leadership

• 10+ years people management, leadership and mentoring experience

• May require up to 25% travel

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