Senior Director, Global Clinical Operations

Jobtailor; Cambridge (MA); Hybrid; USD 180,000 - 340,000; Full time

Job summary

Jobtailor in Cambridge, MA seeks a Senior leader to provide strategic and operational leadership across multiple clinical trials, set operating strategy, and develop a high-performing team of clinical operations professionals. You will ensure trials comply with ICH/GCP and SOPs while managing budgets, timelines, and resourcing.

The role involves CRO/vendor oversight, cross-functional collaboration, and readiness for regulatory inspections.

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 12+ years in clinical operations within biotech/pharma/CRO with people leadership.
• Phase 1-3 global trial management experience, including first-in-human studies.
• Directly oversaw global CROs and managed multi-site trials.
• Strong communication with senior leadership and cross-functional teams.

Responsibilities

• Provide strategic and operational leadership across multiple clinical trials or a full clinical program
• Set clinical operations strategy for assigned programs or indications
• Lead and develop a team of clinical operations professionals
• Ensure trials are conducted according to protocols, SOPs, GCP, departmental goals, and corporate goals
• Collaborate with CROs, vendors, site management, and governance bodies
• Own delivery of assigned programs including budgets, timelines, resourcing, quality and risk mitigation
• Lead trial execution across phases in compliance with ICH/GCP and regulatory requirements
• Provide senior-level oversight to cross-functional teams and external partners
• Represent Clinical Operations during regulatory inspections
• Input into protocols, ICFs, investigator brochures, and study reports

Skills

Clinical Operations Leadership

Global Trial Management

CRO Oversight

Regulatory Compliance

Operational Strategy Development

Budget Management

Risk Mitigation

Leadership & Mentoring

Cross-functional Collaboration

AI Tools Usage

Tools

CTMS

ETMF

IRT

EDC Platforms

Microsoft Office

Job description

Jobtailor in Cambridge, MA seeks a Senior leader to provide strategic and operational leadership across multiple clinical trials, set operating strategy, and develop a high-performing team of clinical operations professionals. You will ensure trials comply with ICH/GCP and SOPs while managing budgets, timelines, and resourcing.

The role involves CRO/vendor oversight, cross-functional collaboration, and readiness for regulatory inspections.