Senior Manager - Clinical Operations

September 30

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Nuvalent, Inc.

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Description

• The Company: • With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. • The Role: • Reporting to the Clinical Operations Study Oversight Lead, the Sr. Manager, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. • You will lead a clinical study with responsibilities including site selection, contract negotiation, budget management, study start-up, conduct and close-out. • This role will be responsible for collaborative oversight of a cross-functional study team as well as excellent management of and partnership with CROs and vendors. • The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharmaceutical company and delivering high quality clinical trial results. • 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. • Evaluate, select, and ensure appropriate oversight of CROs and other external vendors. • Ensure clinical trials are executed according to scope of work, budget, timelines, KPIs, and goals. • 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 manage 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. • 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.

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.