Senior Director Clinical Operations - Home Based (US)
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
The Senior Director, Clinical Operations is a senior leadership position responsible for the strategic planning, tactical execution, and day-to-day management of clinical investigations involving human subjects. The role ensures compliance with corporate objectives, regulatory requirements, and global standards such as ICH-GCP, Good Clinical Practice, and local regulations
Primary Functions
Strategic & Operational Leadership: Develop and execute accurate operational development plans for assigned clinical trials, aligning with budget, timelines, and standard operating procedures (SOPs)
Trial Management: Oversee the management of clinical studies, including compliance with corporate, regulatory, and quality standards.
Team & Vendor Oversight: Lead clinical operations personnel, contract research organizations (CROs), consultants, core laboratories, and other study support organizations.
Program-Level Responsibilities: Handle program-level activities as assigned, ensuring operational plans are implemented effectively.
Compliance & Quality: Ensure adherence to ICH-GCP, GPP, Incyte SOPs, and applicable country-specific regulations.
Collaboration: Work cross-functionally with internal teams (e.g., Medical Affairs, Medical Science Liaisons, Medical) and external partners to support trial goals and timelines.
Key responsibilities include:
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.
Your Profile:
You will bring significant clinical operations experience, with a track record of building high-performing teams and delivering results.
Required qualifications and experience:
Bachelor's degree in life sciences or related field; advanced degree preferred.
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
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
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