Global Director, Data Management & Compliance Excellence

Moderna Therapeutics; Cambridge (MA); On-site; USD 167,000 - 300,700; Full time

Benefits offered by this job

Healthcare benefits

Well-being resources

Family planning

Paid time off

Savings & investments

Location-specific perks

Job summary

Moderna Therapeutics seeks a Director of Data Management Operational Excellence to design and advance the global operating model for Data Management and Clinical Data Standards, driving standardization, governance, and digital enablement across the development portfolio.

This senior leader translates portfolio strategy into execution, mitigates regulatory risk, and ensures inspection readiness through robust oversight, metrics, and process harmonization.

Qualifications

• Bachelor’s degree in life sciences or related analytical field required; advanced degree preferred.
• 10+ years of progressive clinical data management experience with global studies across Phase I–IV, required.
• Demonstrated experience leading operational excellence, transformation, or large-scale process harmonization initiatives.
• Proven experience designing and implementing governance frameworks, KPI systems, and performance analytics models at portfolio level.
• Demonstrated experience in vendor oversight strategy and performance governance within outsourced operating models.
• Experience advancing digital innovation, automation, or analytics-driven process optimization within clinical development preferred.
• Exceptional leadership, influence, and executive communication skills for alignment across senior stakeholders.
• Strong analytical and strategic thinking, translating regulatory and operational requirements into scalable execution.
• Demonstrated ability to learn GxP regulations (GCP, GCDM, GDocP) and ensure compliance across programs.
• Extensive experience leading regulatory GCP inspections and audits with cross-functional coordination.

Responsibilities

• Designing and evolving the global Data Management operating model for consistency, scalability, and regulatory compliance across Therapeutic Areas and development phases.
• Establishing enterprise-wide governance frameworks, standardized processes, and decision-rights models for harmonized execution and risk transparency.
• Defining and overseeing a KPI and performance analytics framework for proactive risk detection and portfolio insights.
• Driving inspection readiness by embedding audit-ready processes, documentation standards, and traceability controls.
• Representing Data Management during regulatory inspections and health authority interactions.
• Overseeing vendor governance, performance standards, and risk escalation pathways.
• Partnering with Clinical Operations, Biometrics, Quality, Regulatory, and Digital to strengthen data flow and interoperability.
• Leading enterprise process harmonization initiatives, SOP strategy, and global standard implementation.
• Championing digital enablement and automation to improve efficiency and reduce manual risk points.
• Identify and mitigate systemic operational risks via governance forums and escalation pathways.
• Influence resource modeling and portfolio capacity planning for pipeline growth.
• Build organizational capability by developing operational excellence competencies and mentoring leaders.
• Assign deputies to support business during absences and establish succession plans.
• Foster an inclusive culture promoting collaboration and continuous improvement.
• Adhere to GxP regulations and Good Documentation Practices across programs.

Skills

Executive leadership

Data management

Regulatory inspections

Governance frameworks

KPI analytics

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

Moderna Therapeutics seeks a Director of Data Management Operational Excellence to design and advance the global operating model for Data Management and Clinical Data Standards, driving standardization, governance, and digital enablement across the development portfolio.

This senior leader translates portfolio strategy into execution, mitigates regulatory risk, and ensures inspection readiness through robust oversight, metrics, and process harmonization.