Senior Director, Clinical Operations & Trials Strategy

Collegium Pharmaceutical, Inc.

Boston (MA)

Hybrid

USD 215,000 - 253,000

Full time

14 days+
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Job summary

Collegium Pharmaceutical is seeking a senior clinical operations leader to drive strategic planning, financial oversight, and end-to-end execution of clinical trials across Phases I–IV. You will supervise CROs and external vendors, ensure data integrity, and maintain regulatory compliance while delivering studies on time and within budget.

The role requires extensive experience in budgeting, contract negotiations, and cross-functional leadership, with a hybrid onsite work arrangement in

Qualifications

  • B.A. or B.S. in life sciences with strong clinical trial background.
  • 8+ years in pharma/biotech clinical trials, with leadership or oversight of execution.
  • Experience in budgeting, contract negotiations, and regulatory compliance.

Responsibilities

  • Develop operational strategies for trials (Phase I–IV) and ensure on-time delivery within budget.
  • Oversee CROs, external vendors, and trial sites to meet quality standards.
  • Maintain integrated study timelines and risk mitigation plans.
  • Lead contract and budget negotiations with CROs and vendors, and monitor performance and costs.
  • Ensure GCP/ICH/FDA compliance and inspection readiness across trial documents and SOPs.

Skills

Clinical trial management
Regulatory compliance
Budgeting & contracting
Cross-functional leadership
Vendor management

Education

B.A. or B.S. in life sciences

Tools

Microsoft Office
EDC systems

Job description

Collegium Pharmaceutical is seeking a senior clinical operations leader to drive strategic planning, financial oversight, and end-to-end execution of clinical trials across Phases I–IV. You will supervise CROs and external vendors, ensure data integrity, and maintain regulatory compliance while delivering studies on time and within budget.

The role requires extensive experience in budgeting, contract negotiations, and cross-functional leadership, with a hybrid onsite work arrangement in

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