Note: The job is a remote job and is open to candidates in USA. ICON Strategic Solutions is a leader in clinical research, and they are seeking a Senior Director of Clinical Operations for their Hematology division. This role is responsible for the strategic planning and execution of clinical investigations, ensuring compliance with regulatory requirements and management of clinical studies.
Responsibilities
- Develop and execute accurate operational development plans for assigned clinical trials, aligning with budget, timelines, and standard operating procedures (SOPs)
- Oversee the management of clinical studies, including compliance with corporate, regulatory, and quality standards
- Lead clinical operations personnel, contract research organizations (CROs), consultants, core laboratories, and other study support organizations
- Handle program-level activities as assigned, ensuring operational plans are implemented effectively
- Ensure adherence to ICH-GCP, GPP, Incyte SOPs, and applicable country-specific regulations
- Work cross-functionally with internal teams (e.g., Medical Affairs, Medical Science Liaisons, Medical) and external partners to support trial goals and timelines
- Accountable for the development and execution of operational plans for direct trial responsibilities
- Manage recruitment, completion, and budgeting of R&D-sponsored trials within timelines
- Oversee local CRAs and vendor oversight for sponsored trials
- Plan and execute clinical trial goals, ensuring compliance with quality and timelines
- Represent local regions in global study team meetings, providing feedback and insights
- Ensure timely submission and approval of ethical and administrative submissions for in-house studies
- Monitor site performance, feasibility, and study execution for assigned trials
Skills
- Bachelor's degree in life sciences or related field
- Extensive experience in clinical operations within the pharmaceutical, biotechnology, or CRO industry
- Ability to manage complex, multi-site trials across global regions
- Proven track record of successfully leading and managing clinical trials from start to finish
- Non-malignant hematology experience, Von Willebrand disease, required
- Acquisition experience required
- Strong understanding of regulatory requirements and GCP guidelines
- Excellent communication, leadership, and problem-solving skills
- Willingness to travel as required (approximately 20%)
- To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status
- Advanced degree preferred
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