Associate Director, Clinical Operations – Oncology Trials Lead

Monte Rosa Therapeutics, Inc.; Boston (MA); Hybrid; USD 150,000 - 190,000; Full time

Job summary

Monte Rosa Therapeutics, Inc. is seeking an Associate Director, Clinical Operations to lead planning, implementation, and conduct of clinical trials across multiple indications.

Hybrid work with 70% office presence in Boston; travel 30-40% for site visits and meetings. You will oversee program strategy, manage budgets, timelines, CROs, vendors, and data management partnerships, ensuring GCP/ICH compliance and high-quality deliverables.

Qualifications

• Bachelor's degree required in health sciences or related field.
• At least 10 years in global clinical trial and program operations.
• 4+ years independently managing trials across phases.
• Experience in oncology or autoimmune/inflammatory diseases.
• Deep knowledge of FDA regulations and ICH/GCP.

Responsibilities

• Deliver assigned clinical program budgets, timelines, and resources.
• Collaborate on development and execution of trial strategy.
• Represent Clinical Operations in core team meetings.
• Lead and oversee execution of trials to meet timelines and budget.
• Manage CROs and vendors for trial operations.
• Develop study timelines and report metrics.
• Lead vendor sourcing and negotiations.
• Forecast trial budget and provide reporting to finance.
• Ensure compliance with ICH/GCP and SOPs.
• Cultivate relationships with investigators and sites.
• Partner with Data Management for data review plan and milestones.
• Monitor KPIs and identify process improvements.

Skills

Clinical operations leadership

Stakeholder collaboration

Risk management

Data analysis

Communication

Regulatory knowledge

Education

Bachelor's degree in health sciences or related field

Tools

Excel

Word

PowerPoint

Outlook

MS Project/Smartsheet

Job description

Monte Rosa Therapeutics, Inc. is seeking an Associate Director, Clinical Operations to lead planning, implementation, and conduct of clinical trials across multiple indications.

Hybrid work with 70% office presence in Boston; travel 30-40% for site visits and meetings. You will oversee program strategy, manage budgets, timelines, CROs, vendors, and data management partnerships, ensuring GCP/ICH compliance and high-quality deliverables.