Clinical Operations Director: Strategy, Budget & Trials

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

Job summary

Collegium Pharmaceutical is seeking a senior clinical operations leader to direct strategy, financial oversight, and end-to-end execution of trials from protocol through final study report. You will oversee CROs and external vendors, manage cross-functional teams, and drive timelines, supply, and quality to ensure efficient trial delivery.

The role emphasizes regulatory compliance, data integrity, and continuous process improvement within a hybrid work model based in Stoughton, MA.

Qualifications

• Experience leading or overseeing clinical trial execution in pharma/biotech.
• Strong budgeting, financial tracking, and contract negotiation skills.
• Deep understanding of FDA regulations and ICH-GCP guidelines governing clinical trials.
• Ability to work cross-functionally across study teams and vendors.

Responsibilities

• Develop operational strategies for trials spanning Phase I–IV.
• Oversee CROs and external vendors to deliver on time and within budget.
• Manage study timelines, milestones, and recruitment plans.
• Ensure compliance with regulatory requirements and study documentation.

Skills

Clinical trial leadership

Budgeting & forecasting

FDA & ICH-GCP knowledge

Cross-functional collaboration

Vendor management

Communication skills

Education

B.A. or B.S. in a scientific field

Tools

Microsoft Office

EDC systems

Job description

Collegium Pharmaceutical is seeking a senior clinical operations leader to direct strategy, financial oversight, and end-to-end execution of trials from protocol through final study report. You will oversee CROs and external vendors, manage cross-functional teams, and drive timelines, supply, and quality to ensure efficient trial delivery.

The role emphasizes regulatory compliance, data integrity, and continuous process improvement within a hybrid work model based in Stoughton, MA.