Senior Director, Clinical Operations

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🔥 6 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• 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. • Monitor site performance, feasibility, and study execution for assigned trials.

🎯 Requirements

• 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. • Strong understanding of regulatory requirements and GCP guidelines. • Excellent communication, leadership, and problem-solving skills. • Willingness to travel as required (approximately 20%) • Must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status.

🏖️ 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