Senior Manager, Clinical Operations

Summary

Join Nuvalent, a dynamic early-stage company focused on developing cancer treatments, as a Senior Manager of Clinical Operations. Reporting to the Director, Clinical Operations, you will lead and manage clinical studies, ensuring excellence in planning, execution, and data collection. Key responsibilities include site selection, contract negotiation, budget management, and cross-functional team leadership. The ideal candidate possesses extensive experience in clinical operations within the biotech/pharmaceutical industry, a strong understanding of ICH-GCP guidelines, and proven success in managing complex clinical trials. This role requires strong project management, communication, and leadership skills. The position offers the opportunity to contribute to a growing organization and make a significant impact on the development of life-saving medicines.

Requirements

• At least 5 - 7 years of Clinical Operations experience
• Bachelor’s degree or higher in a scientific or healthcare discipline preferred with 7+ years relevant experience within the biotech, pharmaceutical, or CRO industry
• Extensive knowledge of ICH-GCP guidelines
• Relevant experience managing early through late Phase clinical trials
• Experience in managing oncology global Phase 3 clinical trials
• Demonstrated cross-functional leadership fostering team spirit and team motivation
• Capability to challenge status-quo using risk management approach
• Able to thrive in a remote/virtual environment

Responsibilities

• Lead and manage one or multiple clinical studies and demonstrate thorough knowledge of clinical operations’ project management
• Lead cross-functional clinical study team to support clinical study delivery
• Evaluates, selects, and ensures appropriate oversight of CROs and other external vendors
• Ensures clinical trials are executed according to scope of work, budget, timelines, KPIs, and goal
• Establish and maintain effective communication and collaboration with functional area peers to meet clinical study objectives and support goals
• Identify risks and propose solutions to facilitate clinical studies
• Develop and manages the study-level budget(s) and demonstrates accountability for the management of the budgets through managing the review and approval of contracts and/or work order changes; manages budget forecasting and accruals in collaboration with finance
• Oversee and manage the creation, maintenance, QC and close out of TMF activities
• Ensure appropriate oversight of enrollment, site activation and data collection milestones
• Contribute to and support team to ensure the completeness of study documents including, study protocol, investigator brochure, informed consent forms, clinical study reports and case report forms
• Collaborate with the Clinical Data Manager to ensure timely and efficient database lock Participate in data review and reconciliation efforts
• Mentor junior team members by delegating study related responsibilities, overseeing, and supporting development plans
• Lead or co-lead department initiatives to support an expanding organization

Preferred Qualifications

• Bachelor’s degree or higher in a scientific or healthcare discipline
• 7+ years relevant experience within the biotech, pharmaceutical, or CRO industry