Associate Director, Clinical Operations
Nuvalent, Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $171,000 - $200,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- 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%).
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.
- Leadership experience in regulatory inspections preferred.
- 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.
Benefits
- medical, dental, and vision insurance
- 401(k) retirement savings plan
- generous paid time off (including a summer and winter company shutdown)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical operationsproject managementbudget managementdata collectionTMF managementclinical trial executionrisk managementdatabase lockclinical study documentationKPI management
Soft skills
leadershipcommunicationcollaborationmentoringproblem-solvingteam motivationaccountabilitycross-functional leadershipstrategic inputdelegation