Director Clinical Operations

4 weeks ago


Durham, United States Life Science People Full time

Company Overview:


Dynamic and innovative company dedicated to advancing healthcare through cutting-edge research and development. We are committed to improving patient outcomes and transforming the landscape of healthcare. As we continue to grow, we are seeking a highly skilled and experienced Director of Clinical Operations to join our team in Durham, North Carolina.


Position Overview:

We are looking for a strategic and results-driven professional to lead our Clinical Operations team in Durham. The Director of Clinical Operations will play a pivotal role in the planning, execution, and oversight of our clinical trials and research programs. The successful candidate will bring extensive experience in clinical operations, a deep understanding of regulatory requirements, and the ability to lead cross-functional teams.


Key Responsibilities:

  1. Strategic Leadership:
  • Develop and implement strategic plans for the successful execution of clinical trials, ensuring alignment with overall corporate objectives.
  • Provide leadership and guidance to the Clinical Operations team to achieve operational excellence.
  1. Clinical Trial Management:
  • Oversee the planning, initiation, and execution of clinical trials from Phase I to Phase III.
  • Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Data Management, to ensure seamless trial progression.
  1. Regulatory Compliance:
  • Ensure compliance with local and international regulatory requirements and industry standards.
  • Work closely with Regulatory Affairs to address regulatory issues and contribute to the preparation of regulatory submissions.
  1. Resource Management:
  • Manage and optimize resources, including budget, timelines, and personnel, to meet project goals.
  • Implement best practices for efficient and cost-effective clinical trial operations.
  1. Vendor Management:
  • Select and manage relationships with CROs, vendors, and other external partners.
  • Negotiate contracts and oversee the performance of external partners to ensure quality and compliance.


Qualifications:

  • Bachelor's or advanced degree in a relevant field (e.g., Life Sciences, Pharmacy, Nursing).
  • Minimum of 10 years of experience in clinical operations, with at least 4 years in a leadership role.
  • Proven track record of successfully managing clinical trials from start to finish.
  • Strong knowledge of regulatory requirements and guidelines.
  • Excellent leadership and communication skills, with the ability to collaborate effectively across departments.
  • Demonstrated ability to make strategic decisions and drive results.


Location:

Durham, North Carolina



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