Senior Manager, Clinical Operations

Senior Manager – Clinical Operations

With deep expertise in chemistry, Nuvalent is creating selective medicines to address the needs of patients with cancer.  Nuvalent is an exciting early-stage company and brings together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. 

The Role:

Nuvalent is seeking a highly motivated, patient-focused, results-orientated team member for our growing Clinical Operations organization. The Senior Manager Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. They will be responsible for multiple aspects of clinical study conduct, including site selection, budget management, study start-up, conduct and close-out. Providing appropriate escalation of trial specific issues to deliver high quality clinical trial results. Able to adapt to changes in the work environment and manage competing demands.

 Responsibilities:

• Manage one or multiple clinical studies and demonstrate thorough knowledge of clinical operations’ project management
• Accountable for the delivery of project(s) to achieve agreed timelines, scope, and quality. Manage vendors, and budgets to ensure the timely and cost-effective implementation of clinical trials
• Assess CRO and auxiliary vendor capabilities for implementation of clinical development plan
• Manage the review and approval of contracts and/or work order changes
• Oversees and manages CRO and other study vendors to ensure that clinical trials are executed according to scope of work and set performance standards and goals
• Oversee and manage the creation, maintenance and close out of TMF activities
• Ensure appropriate oversight of enrollment, site activation and data collection milestones
• Co-lead clinical study team to support clinical study delivery
• 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
• Identify risks and broker solutions to facilitate clinical studies
• Delegate study related responsibilities to Clinical Operations contract staff and junior team members
• Establish and maintain effective communication and collaboration with functional area peers to meet clinical study objectives and support goals
• Lead or co-lead department initiatives to support an expanding organization
• Travel may be required (10% – 15%)

Competencies Include:

• Detail and process orientated, with excellent project management skills, including risk assessment and contingency planning
• Excellent problem solving, communication and organization skills 
• Flexibility with changing priorities, ability to think critically, strong attention to detail, and ability to work well under pressure
• Ability to work in a collaborative environment and build effective working relationships across the organization
• Demonstrated leadership and ability to strategically plan, organize and manage multiple projects simultaneously 

Qualifications:

•  Bachelor’s degree or higher in a scientific or healthcare discipline preferred with 5+ years relevant experience in clinical operations within the biotech, pharmaceutical or CRO industry
• Extensive knowledge of ICH-GCP guidelines
• Relevant experience managing early through late Phase clinical trials
• Knowledge of oncology clinical trials preferred
• Cross-functional leadership fostering team spirit and team motivation
• Capability to challenge status-quo using risk management approach
• Experience in managing international clinical trials