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:
- 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.
- 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.
- 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.
- 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.
- 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