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Cambridge, Massachusetts, United States
Onsite
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 & Benefits
At 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.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Our Working Model
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.
Moderna is a smoke-free, alcohol-free, and drug-free work environment.
Equal Opportunities
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accommodations
We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
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