Director, Clinical Ops: Strategy & CRO Oversight (Hybrid)

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

Job summary

Collegium Pharmaceutical is seeking a senior leader to oversee the strategic planning, financial oversight, and end-to-end execution of clinical trials. Based in Boston, this hybrid role will coordinate with CROs and internal teams to deliver studies on time and within budget.

The ideal candidate will ensure regulatory compliance (FDA/ICH-GCP), manage Trial Master File integrity, and drive operational improvements across programs from Phase I to IV.

Qualifications

• 8+ years of clinical trial experience in pharma/biotech.
• Expertise in FDA regulations and ICH-GCP guidelines.
• Strong budgeting, tracking, and contract negotiation skills.
• Excellent organizational and cross-functional collaboration abilities.
• Clear communication across levels and updated knowledge of EDC systems.

Responsibilities

• Strategize and oversee clinical programs from Phase I–IV.
• Ensure end-to-end trial delivery within protocol and timelines.
• Develop and maintain integrated study timelines and milestones.
• Identify risks and implement mitigations.
• Lead site selection and patient recruitment strategies.
• Oversee CROs and external vendors, managing budgets and performance.
• Ensure compliance with GCP, FDA, and regulatory requirements.
• Provide leadership to cross-functional teams and partners.

Skills

Clinical operations

Budgeting

Contract negotiations

Cross-functional leadership

Regulatory knowledge

EDC systems

Communication

Education

Bachelor's degree in life sciences

Tools

MS Office

EDC systems

Job description

Collegium Pharmaceutical is seeking a senior leader to oversee the strategic planning, financial oversight, and end-to-end execution of clinical trials. Based in Boston, this hybrid role will coordinate with CROs and internal teams to deliver studies on time and within budget.

The ideal candidate will ensure regulatory compliance (FDA/ICH-GCP), manage Trial Master File integrity, and drive operational improvements across programs from Phase I to IV.