Senior Director Clinical Operations - Home Based (US)
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
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
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here
Are you a current ICON Employee? Please click here to apply
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
