Senior Clinical Operations Leader: Oncology Trials

Monte Rosa Therapeutics, Inc; Boston (MA); Hybrid; USD 180,000 - 270,000; Full time

Job summary

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

Reporting to the Head of Clinical Operations, you will be accountable for operational program strategy and the execution of First in Human through Phase III trials, collaborating with cross-functional teams. This role requires robust experience in oncology or autoimmune diseases, oversight of CROs and

Qualifications

• Bachelor's degree in health sciences or related field.
• 10+ years of global clinical trial and program operations experience with at least 4 years of independent clinical trial management through all phases.
• Robust experience in oncology and/or autoimmune and inflammatory diseases.
• Experience with developing clinical operations strategy and plans including site monitoring, risk mitigation plans, recruitment plans, enrollment modeling and CRO/vendor oversight plans.
• Experience with managing and demonstrating oversight of CROs, vendors and consultants.
• Extensive knowledge and application of current FDA Regulations, ICH/GCP guidelines in clinical trials.
• Strong computer skills including Excel, Word, PowerPoint, Outlook and MS Project/Smartsheet.
• Outstanding ability to communicate openly and clearly with internal partners and external service providers.
• Ability to collaborate effectively with study teams using collaborative negotiation skills.
• Proficiency in risk management to prevent and address safety and compliance issues.
• Willingness to travel up to 20%.

Responsibilities

• Deliver assigned clinical program budgets, timelines, and resource management with focus on quality.
• Collaborate on development, planning, and execution of clinical operations program strategy for multiple indications.
• Represent Clinical Operations at cross-functional core team meetings.
• Lead execution of trials to meet timelines, budget, and quality standards.
• Manage CRO/vendor relationships across all aspects of clinical trial operations.
• Establish study timelines and track metrics.
• Develop and execute Clinical Trial Operations Strategy and vendor oversight plans.
• Lead CRO/vendor selection and RFP/bid defense processes.
• Provide ongoing reporting and forecasting to finance.
• Ensure adherence to ICH/GCP and SOPs; uphold high ethical standards.
• Foster relationships with Investigators, site staff, and CRO partners.
• Oversee Data Management in partnership with Medical Directors and data review processes.
• Define KPIs and pursue process optimizations.
• Represent operations to external stakeholders.
• Additional duties as required.

Skills

Clinical operations leadership

Cross-functional collaboration

Regulatory knowledge (FDA/ICH/GCP)

Data analysis and reporting

Vendor management

Education

Bachelor's degree in health sciences or related field

Tools

MS Project/Smartsheet

Excel

Word

PowerPoint

Outlook

Job description

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

Reporting to the Head of Clinical Operations, you will be accountable for operational program strategy and the execution of First in Human through Phase III trials, collaborating with cross-functional teams. This role requires robust experience in oncology or autoimmune diseases, oversight of CROs and