ICON plc

Senior Director Clinical Operations

ICON plc$150K — $180K *
US-AnywhereRemote in Blue Bell, PA
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in life sciences required; advanced degree preferred.
  • Extensive experience in clinical operations in pharmaceutical, biotechnology, or CRO sectors.
  • Ability to manage complex, multi-site trials on a global scale.
  • Proven track record of successfully leading clinical trials from start to finish.
  • Strong understanding of regulatory requirements and GCP guidelines.
  • Excellent communication, leadership, and problem-solving abilities.
  • Willingness to travel approximately 20%.
  • Legally authorized to work in the U.S. without requiring sponsorship.

Responsibilities

  • Develop and execute operational plans for clinical trials aligned with budget and timelines.
  • Oversee management of studies to ensure compliance with standards.
  • Lead clinical operations teams and manage vendor relationships effectively.
  • Handle program-level activities, ensuring operational plans are implemented successfully.
  • Ensure adherence to ICH-GCP and applicable regulatory standards.
  • Collaborate with internal and external stakeholders to meet trial objectives.
  • Monitor site performance and manage the execution for assigned trials.

Benefits

  • Competitive base salary and performance-related incentives.
  • Health and wellbeing programs including medical, dental, and vision coverage.
  • Retirement and pension plans available.
  • Life assurance and disability coverage included.
  • Employee assistance programs and wellbeing resources.
  • Learning and development opportunities through structured training.
Full Job Description
Senior Director Clinical Operations - Home Based (US)

TheSenior Director, Clinical Operationsis 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.

  • 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:

  • 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

Benefits may vary depending on role and location.


Visit our to read more about the benefits ICON offers.

About ICON plc

ICON plc is a global provider of drug development and commercialisation services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development. ICON has approximately 15700 employees in 40 countries. The company was founded in Dublin, Ireland in 1990 and is headquartered in Leopardstown, Dublin. ICON has been publicly traded on the NASDAQ since 1998.
Learn more about ICON plc
Size
39,300 employees
Market Cap
$16.2 billion
Industry
Net Income
$332.3 million
Founded
2017
5 Year Trend
+26.9%
Revenue
$2.7 billion
NASDAQ

Similar Jobs

More Jobs at ICON plc

More Pharmaceuticals & Biotech Jobs

Find similar Senior Director Clinical Operations jobs: