Director, Clinical Operations

Role Summary:The Director, Clinical Operations is responsible for ensuring that clinical stage programs achieve strategic and operational objectives within established timelines, budget, and quality standards. This role provides leadership to the Clinical Operations team, contributes to the development of clinical program strategies, and ensures superior execution, collaboration, and transparency across functions. The Director partners with internal stakeholders and external partners to drive high-quality clinical trial delivery in a fast-paced, small-to-midsize biotech environment.Key Responsibilities:Program Strategy & Leadership (35%)Develop and execute clinical program strategies that align with corporate goals. Provide leadership to the Clinical Operations team and ensure efficient resource allocation across programs.Clinical Trial Oversight (25%)Ensure clinical trials are properly defined, planned, and executed according to GCP, ICH, and FDA standards. Oversee study timelines, budgets, and quality metrics to achieve operational excellence.Regulatory & Documentation Support (15%)Assist in authoring key regulatory documents and ensure that clinical program deliverables align with submission requirements and regulatory expectations.Vendor & CRO Management (15%)Manage and oversee CROs, vendors, and external partners to ensure performance, deliverables, and financial accountability meet expectations.Team Development & Collaboration (10%)Foster a collaborative culture within Clinical Operations and serve as a leadership role model. Promote transparent communication, accountability, and operational discipline across the department.Other duties and responsibilities as assigned.