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Nuvalent, Inc. · 3 days ago

Associate Director, Clinical Operations

Cambridge, MA

Full-time

Hybrid

Lead/Staff, Director/Executive

$171K/yr - $200K/yr

8+ years exp

Nuvalent, Inc. is an early-stage company focused on developing selective medicines for cancer treatment. The Associate Director, Clinical Operations will lead clinical trial planning and execution, ensuring compliance with regulatory guidelines and managing cross-functional teams and external vendors.

BiotechnologyLife ScienceTherapeutics

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%)

Qualification

Clinical Operations experienceICH-GCP guidelinesOncology clinical trialsProject managementLeadership experienceProblem solvingCommunication skillsOrganizational skillsTeam collaboration

Required

Bachelor's degree or higher in a scientific or healthcare discipline

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

Preferred

Leadership experience in regulatory inspections

Benefits

Medical, dental, and vision insurance

401(k) retirement savings plan

Generous paid time off (including a summer and winter company shutdown)

Company

Nuvalent, Inc.

Nuvalent is creating precisely targeted therapies for patients with cancer designed to overcome the limitations of existing therapies for clinically proven kinase targets.

Founded in 2017

Cambridge, Massachusetts, USA

51-200 employees