Associate Director, Clinical Operations

Role Overview

• 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.

Tech Stack

• Google Cloud Platform

Benefits

• medical, dental, and vision insurance
• 401(k) retirement savings plan
• generous paid time off
• summer and winter company shutdown