Clinical Operations Director

2 days ago

Reston, Virginia, United States Meet Full time
Job Summary

The Associate Director of Clinical Operations is a key member of our team, responsible for overseeing the planning, coordination, and execution of global clinical trials. This role requires a strong understanding of industry practices, outsourcing, and GCP system requirements.

Key Responsibilities
  • Study Execution: Oversee clinical operations for assigned programs, ensuring compliance with GCP, ICH, and relevant regulations.
  • Global Study Management: Manage global studies, directing Clinical Trial Managers and CRO Study Teams.
  • Clinical Development Planning: Contribute to clinical development planning and strategy.
  • CRO Management: Lead the selection and management of CROs, and oversee investigator recruitment, study start-up, enrollment, data collection, and drug projections.
  • Project Timelines: Develop and manage project timelines to achieve departmental and corporate goals.
  • Risk Management: Identify and implement strategies to address study risks.
  • Performance Tracking: Track KPIs for assigned trials, including clinical reviews and data query resolution.
  • Progress Updates: Provide senior management with timely updates on progress and changes in scope.
  • Investigator Meetings: Oversee the preparation and content of investigator meetings.
  • Site Outreach: Coordinate site outreach and enrollment activities.
  • Stakeholder Communication: Communicate regularly with key stakeholders, including Regulatory Affairs, Biostatistics, Data Management, Clinical Supply, Clinical Research, Legal, and Finance.
  • Regulatory Documents: Contribute to clinical study reports, Investigator's Brochures, protocols, and other regulatory documents.
  • CTMF Management: Ensure the Clinical Trial Master File is current and inspection-ready.
  • Enrollment Feasibility: Assess enrollment feasibility across various indications.
  • Clinical Document Development: Lead or co-lead the development of clinical documents and study-related plans.
Requirements
  • Industry Knowledge: Comprehensive knowledge of industry practices, outsourcing, and GCP system requirements.
  • Collaboration: Strong collaborative skills and the ability to build effective relationships across departments.
  • Regulatory Compliance: Documented training in FDA Regulations, GCP, and ICH guidelines.
  • Communication: Excellent communication and writing skills.
  • Influencing: Effective in influencing and relationship-building.
  • Problem-Solving: Strong problem-solving skills and sound judgment.
  • Leadership: Detail-oriented with experience managing and developing direct reports.
  • Travel: Willingness to travel domestically and internationally (10-15%).
  • Regulatory Experience: Experience with regulatory authority inspections is a plus.
Preferred Qualifications
  • Education: B.A. or advanced degree in biological sciences or a related field.
  • Experience: At least 10 years of experience in clinical operations within biotech, pharmaceutical, or CRO environments, including 5 years managing global clinical trials.
  • Industry Experience: Experience in both early and late phases of development and in immune-mediated diseases.
  • Computer Skills: Proficiency in Microsoft Office (Word, Excel, Outlook), Smartsheet, electronic TMF, and electronic clinical technologies.

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