AVP, Clinical Data Management

What you will do

The Associate Vice President, Clinical Data Management is a member of the Global Development Operations (GDO) leadership team and is a strategic partner to the R&D organization.

The AVP will lead Amgens Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs. This role is responsible for the strategic direction, leadership, and operational oversight of data management processes supporting clinical trials across all therapeutic areas and phases.

This AVP will collaborate closely with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and quality to drive data integrity and compliance with global regulatory standards.

The role requires a visionary leader with deep expertise in CDM and a proven ability to scale and lead global teams in a complex matrix environment.

Responsibilities:

• Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals.
• Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases.
• Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows.
• Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums.
• Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance.
• Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization.
• Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues.
• Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions.
• Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics.
• Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data.
• Build and maintain strategic relationships with CROs, vendors, regulatory authorities, and industry organizations to advance CDM excellence.
• Influence internal leadership and functional partners to promote data-driven decision-making across clinical programs.
• Lead audit readiness efforts and promote a culture of continuous improvement and compliance within the CDM function.
• Implement protocols and tools to ensure data security, integrity, and risk management across all platforms and studies.
• Optimize staffing, outsourcing strategies, and technology investments to improve cost-efficiency, scalability, and delivery timelines.

Basic Qualifications:

• Bachelors or masters degree with 25+ years of data management experience AND
• 10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment.
• Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM).
• Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgens global clinical development efforts.
• Expertise in AI/ML-driven data management solutions, automation, and advanced analytics.
• Understanding of clinical data standards (CDISC, SDTM, ADaM).
• Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions
• Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management.
• Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams.
• Experience managing FSP relationships and technology implementations (EDC, CTMS, RWD/RWE).
• Knowledge of emerging trends in digital health, data governance, and data privacy regulations (GDPR, HIPAA).
• Familiarity with decentralized trial models and digital health technologies.