Note: The job is a remote job and is open to candidates in USA. ICON Strategic Solutions is a global healthcare intelligence and clinical research organization united by a mission to bring new medicines and treatments to patients faster. The Senior Director, Clinical Operations is responsible for the strategic planning, tactical execution, and day-to-day management of clinical investigations involving human subjects, ensuring compliance with corporate objectives and regulatory requirements.
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
- 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
Benefits
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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