Associate Director, Clinical Operations

The Associate Director, Clinical Operations will be responsible for managing operational aspects of assigned clinical trials, with a focus on early-phase oncology studies. This includes oversight of contract research organizations (CROs), vendors, and clinical sites across both U.S. and international regions. The role requires a deep understanding of clinical trial processes, regulatory compliance (GCP, FDA, ICH), and the ability to lead cross-functional teams to ensure high-quality, timely, and cost-effective trial execution. The ideal candidate will bring an in-depth understanding of managing early phase oncology trials at a sponsor biotech.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

Lead the planning, initiation, execution, and close-out of complex Phase I oncology trials. Ensure all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations.

Manage and oversee external partners including CROs, central labs, biometrics, safety vendors, eTMF providers, and others. Ensure deliverables are met on time, within budget, and to quality standards.

Manage, mentor, and support direct reports, fostering professional development and team performance.

Participate in site selection, feasibility assessments, and initiation visits. Build strong relationships with investigators and site staff to support efficient enrollment and high-quality data collection.

Oversee the development and review of essential study documents such as protocols, informed consent forms, case report forms (CRFs), monitoring plans, and study manuals.

Review monitoring reports and ensure timely resolution of issues. Provide guidance to CRO monitors and ensure appropriate sponsor oversight is documented.

Conduct ongoing data reviews and support data cleaning activities. Ensure inspection readiness at all times, including regular review of the Trial Master File (TMF).

Collaborate with finance and legal teams to manage study budgets, review vendor invoices, and negotiate contracts and change orders.

Work closely with internal stakeholders including Clinical Development, Data Management, Regulatory Affairs, Medical Affairs, and CMC to ensure alignment and smooth execution of clinical programs.

Provide guidance and mentorship to junior team members and cross-functional colleagues. Share best practices and contribute to continuous process improvement.

Prepare and deliver study updates, metrics, and presentations to senior leadership. Represent Clinical Operations in internal and external meetings.

Contribute to the development and implementation of SOPs, work instructions, and operational tools to enhance team efficiency and compliance.

Willingness to travel up to 15% for site visits, vendor meetings, and conferences.

Other activities as assigned.