The Role: This is a strategic leadership role responsible for driving the design, management, and implementation of processes and controlled documents to ensure the organization operates in a proactive state of inspection readiness. The successful candidate will partner closely with the Head of Process Management, Training and Execution, as well as Clinical Compliance and Inspection Readiness, to deliver scalable solutions that strengthen compliance, streamline operations, and enable execution excellence.

The ideal candidate brings deep expertise in controlled document strategy and process management, combined with proven leadership skills to drive organizational transformation in a fast-paced and highly regulated environment. This leader will shape and execute strategy, oversee implementation, and foster a culture of quality, innovation, and continuous improvement across the organization.

Here’s What You’ll Do Strategic Leadership & Implementation Lead the development, optimization, and enterprise-wide implementation of Clinical Development processes, controlled documents, and tools to deliver a prioritized pipeline of procedural improvements.

Define and execute the controlled document development and rollout workflow, ensuring scalability and alignment with enterprise needs.

Establish and manage a hybrid strategy framework with vendor partners for SOP list management, ownership, and trial-level implementation.

Process & Compliance Excellence Drive end-to-end process improvement for controlled documents in partnership with mPROVE, ensuring seamless intake through execution.

Conduct SOP and process gap assessments across internal and external stakeholders; lead change management and implementation of solutions.

Align with Compliance and Quality (QIs, QEs, CAPAs, Inspection Findings) to proactively address risks and strengthen inspection readiness.

Technology & Infrastructure Develop and oversee digital solutions (e.g., Smartsheet, validated systems such as Please Review) to track, manage, and mitigate risks associated with controlled document development, training integration, and document versioning.

Implement standardized controlled document templates and digital tools that enable clear ownership (Moderna/CRO/shared) and ensure audit readiness.

Training Strategy & Execution Integrate SOP strategy with training management systems to ensure automated assignment, tracking, and compliance monitoring.

Partner with training curriculum owners to validate structures, strengthen oversight, and ensure consistency across the enterprise.

Metrics, Reporting & Continuous Improvement Define and track KPIs, deliverables, milestones, and timelines for controlled document development and roll-out.

Analyze systems and processes, providing recommendations for optimization or new solutions to enhance compliance and efficiency.

Embed a culture of continuous improvement, identifying opportunities to reduce cost and cycle time while maintaining quality and regulatory rigor.

Provide regular updates through governance forums, leadership reviews, and cross-functional town halls.

Here’s What You’ll Bring to the Table BA/BS required; advanced degree preferred (or equivalent experience)

10+ years in clinical research within pharma/biotech, with demonstrated leadership in training, controlled document strategy, and process management

Proven track record of building and leading high-performing teams; experience developing talent into future leaders

Direct experience with controlled document development within Clinical Development

Strong knowledge of document management systems and digital workflow tools

Deep understanding of CROs, third-party vendors, and collaborative operating models

Solid knowledge of FDA and ICH GCP guidelines and their application to clinical trials

Exceptional communication and influencing skills; able to engage internal and external stakeholders at all levels

Proven ability to drive multiple high-impact initiatives in a fast-paced, results-oriented environment

Under Washington State law, Moderna is required to provide a reasonable estimate of the salary range for the jobs covered by this description.  Base compensation for these positions in Washington State range from $142,500 to $256,500. Actual salary determinations will take into account factors such as work location, prior education and experience, job-related knowledge, and demonstrated skills.  Compensation decisions are made on the facts and circumstances of each case.

In addition to base compensation Moderna employees are eligible for a comprehensive incentive compensation package including an annual cash bonus, new hire equity and an annual refresh, 401(k) match, competitive and inclusive medical, dental, and vision coverage options, flexible spending accounts for medical and dependent care, Life, LTD, and STD insurance, paid family leave offerings, including at least 16 weeks of 100% paid parental leave, adoption, surrogacy, and family-planning benefits, generous paid time off, including: •    Vacation, sick time, and observed Company-wide holidays •    Paid volunteer time to participate within your community •    Discretionary winter holiday shut down •    Paid 4-week sabbatical after 5 years, and every 3 years after

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Lifestyle Spending Accounts to personalize your well-being journey Family planning and adoption benefits Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities Location-specific perks and extras