Director, Clinical Operations & Trial Execution

Collegium Pharmaceutical; Stoughton (MA); Hybrid; USD 215,000 - 253,000; Full time

Job summary

Collegium Pharmaceutical is seeking an experienced leader to own the strategic planning, financial oversight, and end-to-end execution of clinical trials. You will oversee CROs, manage cross-functional study teams, ensure data integrity, and drive efficiencies to deliver studies on time and within budget.

The role requires leading contract negotiations, tracking performance metrics, and maintaining inspection-ready trial master files in compliance with GCP/ICH and FDA requirements.

Qualifications

• B.A. or B.S. with at least 8 years of clinical trial experience in a pharmaceutical/biotech setting.
• Experience leading or overseeing clinical trial execution.
• Familiarity with FDA regulations and ICH-GCP guidelines.

Responsibilities

• Formulate operational execution strategies for clinical programs spanning Phase I–IV trials.
• Own the delivery of clinical trials from protocol development to final study report.
• Manage study timelines, budgets, and CRO/vendor relationships to ensure quality and on-time delivery.
• Identify trial risks and implement mitigation actions; oversee site selection and patient recruitment strategies.

Skills

Budgeting

Financial tracking

Cross-functional collaboration

Communication

Problem solving

Operational management

Education

B.A./B.S.

Tools

Microsoft Office Suite

EDC systems

Job description

Collegium Pharmaceutical is seeking an experienced leader to own the strategic planning, financial oversight, and end-to-end execution of clinical trials. You will oversee CROs, manage cross-functional study teams, ensure data integrity, and drive efficiencies to deliver studies on time and within budget.

The role requires leading contract negotiations, tracking performance metrics, and maintaining inspection-ready trial master files in compliance with GCP/ICH and FDA requirements.