The Role:The Director, Data Management Operational Excellence serves as the enterprise leader accountable for designing and advancing the global operating model for Data Management and Clinical Data Standards. This role drives strategic standardization, performance optimization, governance, and digital enablement to ensure scalable, high-quality, and inspection-ready data delivery across Moderna's development portfolio. As a senior leader within Data Management, the Director translates portfolio strategy into operational execution frameworks, proactively mitigates regulatory and operational risk, and ensures sustainable inspection readiness through robust oversight, metrics, and process harmonization.
Here's What You'll Be Doing:- Leading the strategic design and continuous evolution of the global Data Management operating model, ensuring consistency, scalability, and regulatory compliance across all Therapeutic Areas and development phases.
- Establishing enterprise-wide governance frameworks, standardized processes, and decision-rights models to ensure harmonized execution, accountability, and risk transparency.
- Defining and overseeing a comprehensive KPI and performance analytics framework that enables proactive risk detection, cycle time optimization, quality monitoring, and executive-level portfolio insights.
- Driving inspection readiness strategy for Data Management and Clinical Data Standards by embedding audit-ready processes, documentation standards, traceability controls, and quality oversight mechanisms into routine operations.
- Representing Data Management Operational Excellence as a senior subject matter expert during regulatory inspections, internal audits, and health authority interactions, ensuring confident and consistent messaging.
- Overseeing vendor governance strategy, including performance standards, oversight models, risk escalation pathways, and continuous improvement expectations to ensure compliant and high-performing partnerships.
- Partnering with Clinical Operations, Biometrics, Quality, Regulatory, and Digital functions to strengthen cross-functional data flow, system interoperability, and end-to-end data integrity.
- Leading enterprise process harmonization initiatives, including SOP strategy, playbook development, and global standard implementation to reduce variability and increase inspection resilience.
- Championing digital enablement and automation initiative, advancing technology adoption, analytics capabilities, and intelligent workflow solutions to improve efficiency and reduce manual risk points.
- Identifying and mitigating systemic operational risks through trend analysis, governance forums, and structured escalation pathways, ensuring early intervention and sustainable remediation.
- Influencing resource modeling and portfolio capacity planning to align operational capabilities with pipeline growth and complexity.
- Building organizational capability by developing operational excellence competencies, fostering a culture of continuous improvement, and mentoring leaders within Data Management.
- Identifying and assigning appropriate deputies to support business in times of absence.
- Setting clear goals, objectives, and expectations for team members and monitor execution.
- Providing guidance and direction to employees in alignment with organizational strategies and priorities.
- Inspiring and motivating team members to achieve their full potential.
- Establishing succession plan(s) and employee development plans to support them.
- Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement.
- Following all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
- Executing tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
- Following Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
- Completing training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
Here's What You'll Need (Basic Qualifications):- Education:
- Bachelor's degree in life sciences, health sciences, data sciences, or related analytical field, required; advanced degree preferred.
- Experience:
- 10+ years of progressive clinical data management experience within the pharmaceutical/biotechnology industry, including leadership of global studies across Phase I-IV, required.
- Demonstrated experience leading operational excellence, transformation, or large-scale process harmonization initiatives, required.
- Proven experience designing and implementing governance frameworks, KPI systems, and performance analytics models at a portfolio level, required.
- Demonstrated experience in vendor oversight strategy and performance governance within outsourced operating models, required.
- Experience advancing digital innovation, automation, or analytics-driven process optimization within clinical development, preferred.
- Exceptional leadership, influence, and executive communication skills, with the ability to drive alignment across senior stakeholders and influence without direct authority.
- Strong analytical and strategic thinking capabilities, with demonstrated ability to translate complex regulatory and operational requirements into scalable, sustainable execution frameworks.
- Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations (GCP. GCDM, GDocP):
- Demonstrated ability to interpret, operationalize, and ensure compliance with GxP regulations across programs, with an expert-level understanding of global regulatory requirements, including FDA regulations, ICH GCP guidelines, and industry standards governing clinical data and drug development systems. Extensive experience leading and overseeing regulatory GCP inspections and audits, including strategy, cross-functional coordination, and direct interaction with health authorities.
Pay & BenefitsAt Moderna, we believe that when you feel your best, you can do your best work. That's why our benefits and well-being resources are designed to support you-at work, at home, and everywhere in between.- Competitive healthcare, plus voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Family planning benefits, including fertility, adoption, and surrogacy support
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investments to help you plan for the future
- Location-specific perks and extras
The salary range for this role is $167,000.00 - $300,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
