Global Director, Clinical Monitoring Strategy & Oversight

Moderna; Cambridge (MA); On-site; USD 167,000 - 301,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous PTO & global recharge days

Job summary

Moderna is seeking a Director, Clinical Monitoring Strategy and Oversight to shape Moderna's global monitoring model, covering on-site, remote, centralized, and RBM approaches across the portfolio. This leader ensures regulatory alignment and continuous improvement across insourced and outsourced monitoring programs.

You will drive analytics, automation, AI-enabled insights, and digital capabilities, partner with Clinical Operations, Risk & Compliance, Data Management, and CROs, and mentor

Qualifications

• Bachelor's degree in Life Sciences or related field, advanced degree preferred.
• Minimum 13 years in clinical research or related functions with monitoring leadership.
• Deep knowledge of ICH GCP, ICH E6(R3), ICH E8(R1) and global regulatory expectations.

Responsibilities

• Define and lead Moderna's global clinical monitoring strategy.
• Establish enterprise standards for on-site, remote, centralized, and RBM.
• Incorporate analytics, automation, and AI-enabled insights into monitoring.
• Serve as BPO/SME for leadership, audits, and regulatory interactions.
• Collaborate with Clinical Operations to integrate monitoring into study planning.

Skills

Strategic leadership

Risk-based monitoring

Centralized monitoring

Remote monitoring

CRO oversight

Stakeholder management

Analytics

Team leadership

Education

Bachelor's degree

Tools

RBQM platforms

Monitoring technologies

Data visualization tools

Job description

Moderna is seeking a Director, Clinical Monitoring Strategy and Oversight to shape Moderna's global monitoring model, covering on-site, remote, centralized, and RBM approaches across the portfolio. This leader ensures regulatory alignment and continuous improvement across insourced and outsourced monitoring programs.

You will drive analytics, automation, AI-enabled insights, and digital capabilities, partner with Clinical Operations, Risk & Compliance, Data Management, and CROs, and mentor