Director, Clinical Operations — Global Trials Lead

Monte Rosa Therapeutics; Boston (MA); Hybrid; USD 180,000 - 260,000; Full time

Job summary

Monte Rosa Therapeutics in Boston seeks an Associate Director, Clinical Operations to lead planning, implementation, and conduct of clinical trials across multiple indications, from First in Human through Phase III depending on program lifecycle.

Reporting to the Head of Clinical Operations, you will develop operational program strategy, manage timelines and budgets, oversee CROs and vendors, and ensure ICH/GCP compliance and data quality with cross‑functional teams and investigators.

Qualifications

• Bachelor's degree in health sciences or related field.
• 10+ years global clinical trial and program operations experience; 4+ years independent trial management.
• Experience in oncology or autoimmune/inflammatory diseases.
• Knowledge of FDA regulations and ICH/GCP guidelines.
• Strong vendor oversight and CRO management experience.
• Excellent communication and cross-functional collaboration skills.
• Willingness to travel ~20% and work in a hybrid Boston environment.

Responsibilities

• Lead planning, implementation, and conduct of trials across indications.
• Develop operational program strategy and manage budgets/timelines.
• Represent Clinical Operations in cross-functional core teams.
• Oversee study management teams and CRO/vendor relationships.
• Establish study timelines and track metrics and reporting.
• Ensure adherence to ICH/GCP and internal SOPs.
• Provide oversight of data management and safety reviews.
• Mentor and manage clinical operations staff.

Skills

Leadership

Cross-functional collaboration

Vendor management

Budget management

Regulatory knowledge

Data analysis

Communication skills

Clinical operations

Risk management

Education

Bachelor's degree in health sciences or related field

Tools

Excel

Word

PowerPoint

Outlook

MS Project

Smartsheet

Job description

Monte Rosa Therapeutics in Boston seeks an Associate Director, Clinical Operations to lead planning, implementation, and conduct of clinical trials across multiple indications, from First in Human through Phase III depending on program lifecycle.

Reporting to the Head of Clinical Operations, you will develop operational program strategy, manage timelines and budgets, oversee CROs and vendors, and ensure ICH/GCP compliance and data quality with cross‑functional teams and investigators.