Associate Director, Clinical Operations

Nuvalent, Inc.•Cambridge, MA

2h•Remote

About The Position

With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. Reporting to the Director, Clinical Operations, the Associate Director, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. This role will lead a Phase 2 registrational clinical study with responsibilities including inspection readiness, contract negotiation, budget management, study conduct, and close-out. The Associate Director, Clinical Operations 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.

Requirements

Bachelor’s degree or higher in a scientific or healthcare discipline preferred with relevant experience in the biotech, pharmaceutical, or CRO industry.
Minimum of 8 years of Clinical Operations experience.
Extensive knowledge of ICH-GCP guidelines.
Experience managing early through late Phase global oncology clinical trials
Demonstrated cross-functional leadership fostering team spirit and team motivation.
Capability to challenge status-quo using risk management approach.
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.

Nice To Haves

Leadership experience in regulatory inspections preferred.

Responsibilities

Lead and manage and provide strategic input on 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, and KPIs
Establish and maintain effective communication and collaboration with functional area peers to meet clinical study objectives and support corporate goals.
Identify risks and propose solutions to facilitate clinical studies.
Develop and demonstrates accountability for the management of study budgets through 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.
Travel may be required (10% – 15%).